BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING SCREW

    MDR report key: 13980404 · Received April 1, 2022

    Report

    Report Number
    8030965-2022-02135
    Event Type
    Injury
    Date Received
    April 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKG
    UDI-DI
    07611819328747
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. STERILE PART: PART: 04.614.508S LOT: 7L80531 MANUFACTURING SITE: (B)(4). SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG RELEASE TO WAREHOUSE DATE: JANUARY 25, 2021. EXPIRATION DATE: JANUARY 01, 2031. NON-STERILE PART: PART: 04.614.508 LOT: 77P5278 MANUFACTURING SITE: (B)(4). SUPPLIER: SYNTHES USA HQ, INC RELEASE TO WAREHOUSE DATE: DECEMBER 28, 2020 EXPIRATION DATE: N/A A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. (B)(4). 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 · 0

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT IS SCHEDULED FOR REVISION SURGERY ON MARCH 15, 2022, TO REPLACE SETSCREWS. PATIENT INITIALLY UNDERWENT A PROCEDURE ON DECEMBER 23, 2021, TO TREAT CEREBRAL PALSY. ON AN UNKNOWN POSTOPERATIVE DATE, THE PATIENT TOOK OFF THE OUTER CASTING GEARS AGAINST SURGEON¿S ADVICE. ON MARCH 7, 2022, IT WAS FOUND THAT THE SETSCREWS HAD COME OFF FROM THE OCCIPITAL BONE. THIS REPORT IS FOR A TITANIUM (TI) LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328410 TI LOCKING SCREW POSTERIOR CERVICAL SCREW SYSTEM NKG SYNTHES GMBH 7L80531 07611819328747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention TI LOCKING SCREW - STERILE| TI LOCKING SCREW - STERILE