FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Report
- Report Number
- 1030489-2020-01066
- Event Type
- Injury
- Date Received
- August 11, 2020
- Date of Event
- June 16, 2020
- Report Date
- April 29, 2025
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5 AND IME HAS BEEN 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.
B5 HAS BEEN 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.
ADDITIONAL INFORMATION WAS RECEIVED THAT SPONSOR ASSESSMENT ((B)(6)): NOT RELATED TO THE PROCEDURE AND POSSIBLE RELATED TO THE PLF GRAFTING MATERIAL, INTERBODY FUSION DEVICE AND TO THE POSTERIOR FIXATION SYSTEM.
ADDITIONAL INFORMATION WAS RECEIVED THAT SPONSOR ASSESSMENT (OC MUO): CEC ASSESSED AS CAUSAL RELATED TO THE PROCEDURE AND POSSIBLE RELATED TO THE PLF GRAFTING MATERIAL, INTERBODY FUSION DEVICE AND TO THE POSTERIOR FIXATION SYSTEM.
THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# P1603LII; LOT# M111501AAF; PMA# P000058; UDI# (B)(4), QTY#2. PART# 5540030; LOT# H5406110 ; 510K# K113174; UDI# (B)(4), QTY# 8. PART# 4011022; LOT# 46AK; 510K# K120368; UDI# (B)(4), QTY# 1. PART# P1603MGS; LOT# CCCN16L4; 510K# K082166; UDI# (B)(4), QTY# 2. PART# 1553201080; LOT# 0514330W; 510K# K113174; UDI# (B)(4). QTY# 1. PART# 55410007545; LOT# 0217237W; 510K# K113174; UDI# (B)(4), QTY# 4. PART# 55840007545; LOT# H5282748; 510K# K113174; UDI# (B)(4), QTY# 2. PART# 55840006545; LOT# 0617572W; 510K# K113174; UDI# (B)(4), QTY# 2. 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.
INFORMATION RECEIVED FROM A POST MARKET CLINICAL STUDY- (INFUSE PLF) INFUSE BONE GRAFT WITH MASTERGRAFT STRIP FOR (PLF). PATIENT MEDICAL HISTORY: CURRENTLY CONSUMES ALCOHOL. PRE-OPERATIVE DIAGNOSTICS: STENOSIS WITH DOCUMENTED PRE_OPERATIVE INSTABILITY, RECURRENT DISC HERNIATION, CONCOMITANT LUMBAR DEGENERATIVE DEFORMITY (COBB ANGLE < OR EQUAL TO 30 DEGREES) FROM L2- S1. PATIENT HAD ACUTE EPIDURAL HEMATOMA SURGERY: SURGEON IDENTIFIED COMPRESSIVE HEMATOMA AT L3-L4 AND L4-L5 LEVELS AND WAS ABLE TO CLEAR OUT AROUND THE L4 NERVE ROOT AND ENSURE THAT IT WAS FULLY FREE. DATE OF DIAGNOSIS AS RELATED TO SUBJECTS CANCER: (B)(6) 2020 DATE OF PATHOLOGY REPORT: (B)(6) 2020 CANCER RESULTS: (B)(6) POSITIVE FOR ADENOCARCINOMA; THE LEFT MID LATERAL AND LEFT MEDIAL SHOWED GLEASON 4+4=8 PROSTATE CANCER AND THE RIGHT BASE MEDIAL SHOWED GLEASON 3+3=6 PROSTATE CANCER. LOCATION / TYPE OF CANCER: PROSTATE CANCER RECORDS PENDING FAMILY HISTORY OF CANCER: NA, LAB WORK: YES, LAB DATE: (B)(6) 2019, LAB RESULT: ELEVATED PSA AT 4.25 MEDICATIONS TAKEN WITHIN 30 DAYS OF CANCER DIAGNOSIS: NA, IT WAS REPORTED THAT POST-OPERATIVE PATIENT HAD : POSSIBLE NON-UNION NOTED AT L2-3 ON LUMBAR CT SCAN. DIAGNOSTICS ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: LUMBAR CT SCAN-1 ACTION RESULT: ABNORMAL ACTION DATE: (B)(6) 2020 ACTION INFO: DIAGNOSTIC TESTS PERFORMED: POSSIBLE NON-UNION AT L2-3 INTERVENTIONS ACTION SUBTYPE: OTHER ACTION RESULT: Y- ADDITIONAL SURGERY RECOMMENDED ACTION SUBTYPE: OTHER RELEVANT ACTIONS ACTION RESULT: Y OUTCOME STATUS : PENDING SITE RELATEDNESS ASSESSMENT: THIS EVENT WAS NOT RELATED TO ANY DEVICES AND SURGICAL PROCEDURE USED. SPONSOR RELATEDNESS ASSESSMENT: THIS EVENT WAS POSSIBLY RELATED WITH THE INFUSE KIT, MGS KIT, INTERBODY DEVICE, MULTIAXIAL SCREWS, RODS, SET SCREWS AND NOT RELATED TO THE PROCEDURE AND SURGICAL PROCEDURE USED. TREATMENT GROUP: GROUP 2 - INFUSE 6 + MASTERGRAFT + LOCAL BONE IMPLANT DATE: (B)(6) 2018 SERIOUSNESS ASSESSMENT: NON-SERIOUS PATIENT CAME FOR FOLLOW UP VISIT ON (B)(6) 2018. PATIENT CAME FOR FOLLOW UP VISIT ON (B)(6) 2018. PATIENT CAME FOR FOLLOW UP VISIT ON (B)(6) 2018. PATIENT CAME FOR FOLLOW UP VISIT ON (B)(6) 2019. PATIENT CAME FOR FOLLOW UP VISIT ON (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853583 | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention |