CAPSTONE SPINAL SYSTEM
Report
- Report Number
- 1030489-2020-00084
- Event Type
- Injury
- Date Received
- January 17, 2020
- Date of Event
- July 22, 2019
- Report Date
- April 23, 2025
- Manufacturer
- MSD DEGGENDORF MFG
- Product Code
- MAX
- PMA / PMN Number
- K073291
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION ADDED IN B5 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: B5, G1, G2 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
B5: UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
UPDATED INFORMATION RECEIVED ON 15-JUNE-2021: PROCEDURE DATE : (B)(6) 2019, ADVERSE EVENT DOCUMENT NUMBER(S)ASSOCIATED WITH ADDITIONAL SURGERY:DOCUMENT NUMBER: (B)(4)SUBEVENTNUMBER: 11 DESCRIBE THE ADDITIONAL SURGICAL PROCEDURE: EXTERNAL BONE GROWTH STIMULATOR PLACED LEVELS INVOLVED IN ADDITIONAL SURGICAL PROCEDURE: L3/L4 SPECIFY THE RELATEDNESS OF THE ADDITIONAL SURGICAL PROCEDURE TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE: NOT RELATED USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE?: NOT APPLICABLE.
ON (B)(6)2020, THE PATIENT PRESENTED WITH ONGOING PAIN. IT WAS REPORTED THAT ON (B)(6)2020, SHE WAS GIVEN A TRANSFORAMINAL EPIDURAL INJECTION. SHE WAS INJECTED WITH 40 MG DEPOMEDROL AND 3 ML BUPIVACAINE AT L2-L3.
PATIENT DEMOGRAPHICS: GENDER: FEMALE, AGE: 64 YEARS, WEIGHT: 63 KGS, CLINICAL ID: (B)(6), RACE: WHITE, ETHNICITY: NOT HISPANIC OR LATINO IMPLANT DATE: (B)(6) 2019 DEVICE STATUS: IMPLANTED - REMAINS IN SERVICE TREATMENT GROUP: GROUP 4 - NON-INFUSE + LOCAL BONE STUDY ID: (B)(6) [(INFUSE PLF) INFUSE BONE GRAFT WITH MASTERGRAFT STRIP FOR (PLF)] SOCIAL HISTORY: CURRENTLY CONSUME ALCOHOL IT WAS REPORTED THAT ON (B)(6) 2019, POST-OP, PATIENT STATES THAT LEFT SIDED LEFT BACK PAIN INCREASED, WORSE WITH MOVEMENT, PER PHYSICIAN, SECONDARY TO BULGING DISC L1-2. ONSET DATE: (B)(6) 2019 DESCRIPTION: BULGING DISC L1-2 INTERVENTIONS ACTION SUBTYPE: OTHER REVELANT ACTIONS ACTION RESULT: Y OUTCOME STATUS PENDING REFERRAL TO SPECIALIST SPECIFY: PAIN MANAGEMENT FOR INTERLAMINAR INJECTION SITE RELATEDNESS ASSESSMENT: INTERBODY FUSION : NOT RELATED PLF GRAFTING MATERIAL :NOT RELATED POSTERIOR FIXATION: NOT RELATED SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE :NOT RELATED SURGICAL PROCEDURE: NOT RELATED SPONSOR RELATEDNESS ASSESSMENT: DBM KIT: NOT RELATED INTERBODY DEVICE: POSSIBLE MULTIAXIAL SCREWS :POSSIBLE PROCEDURE: POSSIBLE RODS: POSSIBLE SET SCREWS : POSSIBLE SURGICAL PROCEDURE: POSSIBLE PATIENT DETAILS: RANDOMIZATION ASSIGNMENT: CONTROL RANDOMIZATION DATE: (B)(6) 2019 NUMBER OF LEVELS TO BE TREATED: 3 LEVELS PREGNANT SINCE LAST VISIT 6_WEEKS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2019 PREGNANT SINCE LAST VISIT 3_MONTHS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2019 PREGNANT SINCE LAST VISIT 6_MONTHS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2019 PREGNANT SINCE STUDY SURGERY UNSCHEDULED 1: HAS THE SUBJECT BECOME PREGNANT SINCE THE STUDY SURGERY: NO DATE OF VISIT: (B)(6) 2019 PREGNANT SINCE STUDY SURGERY UNSCHEDULED 2: HAS THE SUBJECT BECOME PREGNANT SINCE THE STUDY SURGERY: NO DATE OF VISIT: (B)(6) 2019 MEDICAL HISTORY: PRIMARY DIAGNOSTIC INDICATION: ALL OTHER DIAGNOSTIC INDICATIONS: STENOSIS WITH DOCUMENTED PRE_OPERATIVE INSTABILITY, CONSECUTIVE LEVELS (FROM L2- S1) THE SUBJECT WILL HAVE TREATED: 3 LEVELS UPDATE RECEIVED ON (B)(6) 2020: ACTION SUBTYPE: INJECTION ACTION RESULT: Y MEDICATION 1: MEDICATION NAME: 40 MG DEPOMEDROL AND 3 ML BUPIVACAINE INJECTION DATE: (B)(6) 2020 LEVELS: L2-L3, DETAILS: TRANSFORAMINAL EPIDURAL INJECTION (B)(6) 2020 VISIT PAIN IS ONGOING HAD EPIDURAL INJECTION ON (B)(6) 2020. PREGNANT SINCE LAST VISIT 12_MONTHS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2020 UPDATE RECEIVED ON (B)(6) 2020: PREGNANT SINCE STUDY SURGERY UNSCHEDULED 3: HAS THE SUBJECT BECOME PREGNANT SINCE THE STUDY SURGERY: NO DATE OF VISIT: (B)(6) 2020 UPDATED INFORMATION RECEIVED ON (B)(6) 2021: PROCEDURE DATE: (B)(6) 2021 ADVERSE EVENT DOCUMENT NUMBER(S) ASSOCIATED WITH ADDITIONAL SURGERY: DOCUMENT NUMBER: (B)(6) SUBEVENT NUMBER: 13 DESCRIBE THE ADDITIONAL SURGICAL PROCEDURE: RIGHT TOTAL KNEE ARTHROPLASTY/MAKOPLASTY LEVELS INVOLVED IN ADDITIONAL SURGICAL PROCEDURE: OTHER, SPECIFY: RIGHT KNEE SPECIFY THE RELATEDNESS OF THE ADDITIONAL SURGICAL PROCEDURE TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE: NOT RELATED USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE?: NOT APPLICABLE UPDATED INFORMATION RECEIVED ON 07-APR-2021: MEDICATION 2: MEDICATION NAME: 10 MG DEXAMETHASONE INJECTION DATE: (B)(6) 2019 OTHER LEVEL, SPECIFY: L-1, DETAILS: TRANSFORAMINAL EPIDURAL INJECTION UPDATED INFORMATION RECEIVED ON 12-APR-2021: LEVEL FOR MEDICATION2: L1-L2 USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE?: NOT APPLICABLE UPDATED INFORMATION RECEIVED ON 15-JUNE-2021: PROCEDURE DATE : (B)(6) 2019 ADVERSE EVENT DOCUMENT NUMBER(S)ASSOCIATED WITH ADDITIONAL SURGERY:DOCUMENT NUMBER: (B)(6) SUBEVENTNUMBER: 11 DESCRIBE THE ADDITIONAL SURGICAL PROCEDURE: EXTERNAL BONE GROWTH STIMULATOR PLACED LEVELS INVOLVED IN ADDITIONAL SURGICAL PROCEDURE: L3/L4 SPECIFY THE RELATEDNESS OF THE ADDITIONAL SURGICAL PROCEDURE TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE: NOT RELATED USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE?: NOT APPLICABLE UPDATED INFORMATION RECEIVED ON 03-AUG-2021: (B)(6) 2021 VISIT PER PATIENT ONGOING PAIN, NO FURTHER TREATMENT SINCE LAST VISIT USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE?: NOT APPLICABLE UPDATED INFORMATION RECEIVED ON 04-AUG-2021: DATE OF VISIT: (B)(6) 2021 PREGNANT SINCE STUDY SURGERY UNSCHEDULED 1: HAS THE SUBJECT BECOME PREGNANT SINCE THE STUDY SURGERY:NO USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE?: NOT APPLICABLE.
UPDATED INFORMATION RECEIVED ON 25-MAR-2021: PROCEDURE DATE: (B)(6) 2021. ADVERSE EVENT DOCUMENT NUMBER(S) ASSOCIATED WITH ADDITIONAL SURGERY: DOCUMENT NUMBER: (B)(4). SUBEVENT NUMBER: 13. DESCRIBE THE ADDITIONAL SURGICAL PROCEDURE: RIGHT TOTAL KNEE ARTHROPLASTY/MAKOPLASTY LEVELS INVOLVED IN ADDITIONAL SURGICAL PROCEDURE: OTHER, SPECIFY: RIGHT KNEE SPECIFY THE RELATEDNESS OF THE ADDITIONAL SURGICAL PROCEDURE TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE: NOT RELATED USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE?: NOT APPLICABLE.
ADDITIONAL INFORMATION WAS RECEIVED THAT BILATERAL LOWER LEG PAIN-PER TELEPHONE CALL NOTED IN ELECTRONIC RECORD-PAIN WORSE OVERNIGHT-WANTS SOMETHING DONE.
UPDATED INFORMATION RECEIVED ON 07-APR-2021: MEDICATION 2: MEDICATION NAME: 10 MG DEXAMETHASONE INJECTION DATE: ON (B)(6) 2019 OTHER LEVEL, SPECIFY: L-1, DETAILS: TRANSFORAMINAL EPIDURAL INJECTION UPDATED INFORMATION RECEIVED ON 12-APR-2021: LEVEL FOR MEDICATION2: L1-L2 USADE/UADE ASSESSMENT : NO COULD DD HAVE LED TO SADE? NOT APPLICABLE.
UPDATED INFORMATION RECEIVED: SPONSOR ASSESSMENT STATED THAT ADVERSE EVENT IS NOT RELATED TO PLF GRAFT, POSSIBLE RELATED TO POST FIX, INTERBODY FUSION AND PROCEDURE.
UPDATED INFORMATION RECEIVED: CEC ASSESSMENT: POSSIBLE RELATED TO THE PROCEDURE AND NOT RELATED TO ANY DEVICE
OUTCOMES TO ADVERSE EVENT: OTHER: PAIN & PMA/510(K) NUMBER: THE FOLLOWING IMPLANTS WERE USED IN THE SURGERY: PRODUCT ID: 2991122, LOT #: H5101833, QTY: 1, 510(K): K073291, UDI: (B)(4). PRODUCT ID: 1555501080, LOT #: 0720360W, QTY: 2, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840005540, LOT #: H5524986, QTY: 2, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840006540, LOT #: H5507378, QTY: 5, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840006535, LOT #: H5434753, QTY: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 5540030, LOT #: H5545615, QTY: 8, 510(K): K113174, UDI: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT PRESENTED WITH STENOSIS AND PRE-DOCUMENTED INSTABILITY. THE PATIENT UNDERWENT TREATMENT OF 3 LEVELS (BETWEEN L2-S1). ON AN UNKNOWN DATE, POST-OP, ABOUT 3 WEEKS AGO, LEFT SIDED BACK PAIN INCREASED (WORSE WITH MOVEMENT). AS PER THE PHYSICIAN, THIS EVENT WAS SECONDARY TO BULGING DISC L1-L2 (THAT WAS SEEN ON MRI DATED (B)(6) 2019). ON THE VISIT DATED (B)(6) 2019, CONTINUOUS WORSENING PAIN WAS REPORTED. THE PATIENT WAS REFERRED TO PAIN MANAGEMENT FOR INTERLAMINAR INJECTION. ON (B)(6) 2019, THE PATIENT HAD LEFT SIDED INJECTION. ON (B)(6) 2019, DURING PATIENT VISIT, IT WAS NOTED THAT THE PATIENT WAS DOING MUCH BETTER AND RIGHT SIDE INJECTION WAS BEING SCHEDULED. ACCORDING TO THE SITE ASSESSMENT, THE ADVERSE EVENT WAS NEITHER RELATED TO SURGICAL PROCEDURE NOR RELATED TO ANY OF THE IMPLANTED DEVICES. ACCORDING TO THE SPONSOR ASSESSMENT, THE ADVERSE EVENT WAS POSSIBLY RELATED TO THE SURGICAL PROCEDURE, INTERBODY DEVICE, MULTI-AXIAL SCREWS, RODS AND SET SCREWS. THE OUTCOME OF THE EVENT IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63119 | CAPSTONE SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, | MAX | MSD DEGGENDORF MFG | 2991122 | H5101833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |