BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI MATRIX SCREW 45MM THREAD LENGTH

    MDR report key: 11702062 · Received April 21, 2021

    Report

    Report Number
    8030965-2021-03128
    Event Type
    Injury
    Date Received
    April 21, 2021
    Report Date
    February 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    UDI-DI
    10705034749310
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6: PART: 04.639.645, SYNTHES LOT: 7813337, SUPPLIER LOT: NA, RELEASE TO WAREHOUSE DATE: OCTOBER 02, 2014, MANUFACTURED BY SYNTHES BRANDYWINE. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: MNI, MNH, NKB, KWP. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS A J&J EMPLOYEE. REPORT SOURCE: THIS REPORT WAS INITIALLY REPORTED ON MARCH 9, 2021 UNDER MANUFACTURER REPORT NUMBER 1526439-2021-00419 FOR DEPUY SPINE. ON APRIL 14, 2021, IT WAS DETERMINED THE DEVICE ACTUALLY WAS THE REPORTING RESPONSIBILITY OF SYNTHES SPINE. THE REPORT IS NOW BEING SUBMITTED UNDER THE CORRECT MANUFACTURER. (B)(4). DEVICE EVALUATED BY MFR: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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 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 THE PATIENT INITIALLY UNDERWENT THE SURGERY ON (B)(6) 2020 FOR L4-L5-S1 ARTHRODESIS. SINCE THEN PATIENT HAD SUFFERED A BREAKAGE OF SCREWS AND VERTEBRAL MATRIX FIXATOR, WITH PROBLEMS AND SEQUELAE CAUSED AFTER L4-L5-S1 ARTHRODESIS, WITH TORSION BREAKAGE AND SUSPENSION BARS AND IMPRINT, WITH NEED OF SURGICAL RE-INTERVENTION, REMOVAL OF FIXATOR AND REARRIDESIS 360. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599329 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ SYNTHES GMBH 04.639.645 7813337 10705034749310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5.5MM TI CURVED ROD 70MM| 6.0MM TI MATRIX SCREW 35MM THREAD LENGTH| 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH| MATRIX LOCKING CAP WITHOUT SADDLE