BEUDAMED
    FDA Adverse Event Death Summary report: N

    4.5MM TI CERCLAGE POSITIONING PIN-STERILE

    MDR report key: 10546761 · Received September 17, 2020

    Report

    Report Number
    8030965-2020-07142
    Event Type
    Death
    Date Received
    September 17, 2020
    Report Date
    August 27, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    UDI-DI
    07611819909892
    PMA / PMN Number
    K992891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: STERILE PART: PART: 498.839S. LOT: 8628004. MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 25.SEP.2013. EXPIRY DATE: 01.SEP.2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART: PART #: 498.839. SYNTHES LOT NUMBER: 8628004. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 05-MAR-2013. NC #: US1072424 WAS GENERATED DURING PRODUCTION, AS THE MACHINE LINE WAS GOING ACROSS THE PRODUCT ETCHING. THE PRODUCTS WERE ACCEPTED, AS THE MACHINE LINES ARE A COSMETIC DISCREPANCY AND VISUAL STANDARD VS189 WAS MADE TO ADDRESS VISUAL NONCONFORMITIES ON CERGLAGE PINS. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION OF PATIENT UNDERGOING A THR REVISION + GT ORIF FOR A VANCOUVER B3 FRACTURE. PATIENT WAS IMPLANTED WITH A TROCH REATHACHAM DEVICE LARGE, F/CABLE SYSTEM. AFTER 4 MONTHS FOLLOW UP, FRACTURE WAS REVISED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT A THR REVISION + GT ORIF FOR A VANCOUVER B3 FRACTURE. PATIENT WAS IMPLANTED WITH A TROCH REATHACHAM DEVICE LARGE, F/CABLE SYSTEM. AFTER 4 MONTHS FOLLOW UP, FRACTURE WAS REVISED. PATIENT PASSED AWAY SECONDARY TO INFECTION. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 4.5MM TI CERCLAGE POSITIONING PIN-STERILE. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014999 4.5MM TI CERCLAGE POSITIONING PIN-STERILE CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH 8628004 07611819909892

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death CERCL-CABLE W/CRIMP Ø1.7| CERCL-CABLE W/CRIMP Ø1.7| CERCL-CABLE W/CRIMP Ø1.7| CERCLAGE-POSITION-PIN F/LCP 4.5+LC-DCP 4| TRD TROCHANTER REATTACHM-DEVICE LRG F/CA