BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 9600184 · Received January 17, 2020

    Report

    Report Number
    1030489-2020-00082
    Event Type
    Injury
    Date Received
    January 17, 2020
    Date of Event
    July 22, 2019
    Report Date
    August 26, 2021
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    PATIENT DEMOGRAPHICS: GENDER- FEMALE, AGE(AT THE TIME OF REPORTED EVENT)-64 YEARS, WEIGHT- 63 KG IT WAS REPORTED THAT ON UNKNOWN DATE,POST-OP, PATIENT ACHINESS IN BILATERAL LOWER LEGS,FEELS LIKE RESTLESS LEGS IS POSITIONAL, IF PATIENT SITS , STANDS OR LIES DOWN TOO LONG HAS TO MOVE APPLIES HEAT AND FEELS BETTER. IT STILL HAS ACHINESS AT NIGHT AND WHEN LIES DOWN. SITE RELATED ASSESSMENT: INTERBODY FUSION DEVICE: NOT RELATED PLF GRAFTING MATERIAL OTHER :NOT RELATED POSTERIOR FIXATION DEVICE :NOT RELATED SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE OTHER:NOT RELATED SURGICAL PROCEDURE PROCEDURE: NOT RELATED SPONSOR ASSESSMENT: USADE ASSESSMENT: CURRENT:NO COULD DD HAVE LED TO SAD: NO RELATEDNESS: DBM KIT; NOT RELATED INTERBODY DEVICE: POSSIBLE MULTIAXIAL SCREWS: POSSIBLE PROCEDURE: POSSIBLE RODS: POSSIBLE SET SCREWS: POSSIBLE SURGICAL PROCEDURE: POSSIBLE UPDATE RECEIVED ON (B)(6) 2020: INTERVENTIONS: ACTION SUBTYPE: INJECTION, ACTION RESULT: Y, MEDICATION 1: MEDICATION NAME: 40 MG DEPO MEDROL AND 3 ML 0.25% BUPIVACAINE, INJECTION DATE: (B)(6) 2020, LEVELS: L2-L3, DETAILS: TRANSFORAMINAL EPIDURAL STEROID INJECTION, ACTION SUBTYPE: OTHER REVELANT ACTIONS, ACTION RESULT: N DATE OF VISIT: (B)(6) 2020, PREGNANT SINCE LAST VISIT 12_MONTHS: HAS THE SUBJECT BECOME PREGNANT SINCELAST VISIT: NO SPONSOR ASSESSMENT: USADE/UADE ASSESSMENT: NO COULD DD HAVE LED TO SADE? NOT APPLICABLE UPDATE RECEIVE ON (B)(6) 2020: PREGNANT SINCE THE STUDY SURGERY: NO DATE OF VISIT: (B)(6) 2020, SPONSOR ASSESSMENT: USADE/UADE ASSESSMENT: NO 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: R68606105 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 15-JUNE-2021: PROCEDURE DATE : (B)(6) 2019, ADVERSE EVENT DOCUMENT NUMBER(S)ASSOCIATED WITH ADDITIONAL SURGERY:DOCUMENT NUMBER: R67967805 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, STILL HAS ACHINESS, ESI DID NOT HELP, P.T. ENDED, ONGOING AT END OF STUDY. 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.

    Additional Manufacturer Narrative · 1

    OUTCOMES TO ADVERSE EVENT: OTHER: PAIN. THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# 2991122; LOT# H5101833; 510K#K073291; UDI# (B)(4); QTY# 1. PART# 1555501080; LOT# 0720360W; 510K#K113174; UDI# (B)(4); QTY# 1. PART# 55840005540; LOT#H5524986; 510K#K113174; UDI# (B)(4); QTY# 2. PART# 55840006540; LOT#H5507378; 510K#K113174; UDI# (B)(4); QTY# 5. PART# 55840006535; LOT#H5434753; 510K#K113174; UDI# (B)(4); QTY# 1. PART# 5540030; LOT# H5545615; 510K#K113174; UDI# (B)(4); QTY# 8. ALTHOUGH IT IS UNKNOWN WHETHER THE PRODUCT 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.

    Description of Event or Problem · 1

    SPINAL PROCEDURE DUE TO UNKNOWN REASON. POST-OPERATIVELY, THE PATIENT ACHINESS IN BILATERAL LOWER LEGS, FEELS LIKE RESTLESS LEGS IS POSITIONAL, IF PATIENT SITS, STANDS OR LIES DOWN TOO LONG HAS TO MOVE APPLIES HEAT AND FEELS BETTER. IT STILL HAS ACHINESS AT NIGHT AND WHEN LIES DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67386 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MDT SOFAMOR DANEK PUERTO RICO MFG 2991122 H5101833

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other