BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW, HEXALOBE (TI-6AI-4V ELI)

    MDR report key: 8799605 · Received July 17, 2019

    Report

    Report Number
    2027467-2019-00033
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    MNI
    UDI-DI
    00844856043688
    PMA / PMN Number
    K081158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE SET SCREW HAVE BEEN UTILIZED IN THIS CASE. THEY ARE OF THE SAME PRODUCT PART NUMBER/DESCRIPTION BUT CONTAIN TWO SEPARATE IDENTIFYING LOT NUMBERS. IT IS UNKNOWN WHICH MANUFACTURING LOT NUMBER BELONGS TO THE BACKED OUT SET SCREW. LOT 8073503 MANUFACTURED 2/23/2018, LOT 8104801 MANUFACTURED 4/25/2018. NO EVALUATION POSSIBLE AT THIS TIME. THE IMPLANT HAS NOT BEEN REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    SET SCREW BACK OUT FOUND AT L4 DURING A POST-OP VISIT CONDUCTED ON (B)(6) 2019. THE SURGEON HAS DECIDED NOT TO PERFORM REVISION SURGERY AT THIS TIME. THE ZODIAC SPINAL FIXATION SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2019 FROM THE T10 THRU L4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594839 SET SCREW, HEXALOBE (TI-6AI-4V ELI) PEDICLE SCREW SPINAL DEVICE MNI ALPHATEC SPINE INC 22015 00844856043688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other