BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW+SS 6.0MMX32.5MM

    MDR report key: 11817391 · Received May 13, 2021

    Report

    Report Number
    3012447612-2021-00148
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    January 12, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    QHP
    UDI-DI
    00880304864948
    PMA / PMN Number
    H190005
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE REPORTS 3012447612-2021-00057 TO 3012447612-2021-00069 AND 3012447612-2021-00137 TO 3012447612-2021-00162. PRODUCT CODE: QHP. THE RETURNED DEVICE WAS EXAMINED AND NO INDICATIONS OF DAMAGE WERE OBSERVED. THE DHR WAS REVIEWED AND NO NONCONFORMANCES OR TEMPORARY DEVIATIONS WERE ASSOCIATED WITH THIS LOT THAT WOULD HAVE IMPACTED THE PERFORMANCE OF THE DEVICE; THERE ARE NO INDICATIONS OF MANUFACTURING-RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION AVAILABLE, THE CAUSE CANNOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR MONTHS POST-OP, THE PATIENT'S SCOLIOSIS CURVE CHANGED FROM 51 DEGREES PRE-OP TO 19 DEGREES POST-OP IN THE LUMBAR REGION, FROM 68 DEGREES PRE-OP TO 50 DEGREES POST-OP IN THE THORACIC REGION, BUT DEVELOPED A TRUNK ROTATION IN THE THORACIC REGION THAT MEASURES 30 DEGREES ON THE INCLINOMETER REDUCES TO 20 DEGRESS IN A PRONE POSITION. THE DECISION WAS MADE TO REMOVE THE CONSTRUCT AND FUSE THE ASSOCIATED LEVELS (T5-L4) TOGETHER. THIS IS REPORT TWENTY FIVE OF THIRTY NINE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719253 SCREW+SS 6.0MMX32.5MM THE TETHER - VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. N/A 3019440 00880304864948

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R