BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW+SS 7.0MMX27.5MM

    MDR report key: 13690733 · Received March 8, 2022

    Report

    Report Number
    3012447612-2022-00058
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    December 2, 2020
    Report Date
    March 7, 2022
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    QHP
    PMA / PMN Number
    H190005
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: QHP. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE SET SCREW LEAD THREAD WAS BENT IN A MANNER CONSISTENT WITH CROSS-THREADING. FUNCTIONAL TESTING CONFIRMED THAT THE SET SCREW WOULD NOT SEAT IN THE TULIP HEAD. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO CROSS THREADING. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TETHER SET SCREW DID NOT FIT WITH THE MATING SCREW INTRA-OPERATIVELY. THE SET SCREW WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. DEVICE EVALUATION BUY THE MANUFACTURER FOUND THE SET SCREW WAS STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479308 SCREW+SS 7.0MMX27.5MM THE TETHER - VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. NA 3020073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown