BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET SCREW (TI-6AL-4V ELI)

    MDR report key: 6066981 · Received October 31, 2016

    Report

    Report Number
    2027467-2016-00085
    Event Type
    Injury
    Date Received
    October 31, 2016
    Report Date
    October 4, 2016
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    NKB
    UDI-DI
    00840967124582
    PMA / PMN Number
    K133221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AT THIS TIME. THE IMPLANT HAS NOT BEEN RETURNED FOR EVALUATION NOR HAS THE IDENTIFYING LOT NUMBER BEEN PROVIDED. UPON THE RECEIPT OF ADDITIONAL INFORMATION AND/OR THE PRODUCT IN QUESTION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 ADDITIONAL INFORMATION PROVIDED BY THE SALES REP. DURING REVISION SURGERY FOR AN UNRELATED ISSUE, BOTH ARSENAL SET SCREWS LOCATED AT THE S1 WERE FOUND TO HAVE BACKED OUT OF THE MATING POLYAXIAL SCREWS. THE SURGEON BELIEVES HE MAY HAVE FORGOTTEN TO FINAL TIGHTEN BOTH OF THE IMPLANTS. UPON REMOVAL, THE SET SCREWS WERE BOTH DISCARDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    REVISION SURGERY WAS CONDUCTED TO REMOVE 2 SET SCREWS WHICH HAD BACKED OUT OF THE S1. NO ISSUE ONCE SET SCREWS REPLACED AND RE-TORQUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719422 SET SCREW (TI-6AL-4V ELI) PEDICLE SCREW SYSTEM NKB ALPHATEC SPINE INC 47127 00840967124582

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization