BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORD 300MM

    MDR report key: 11817446 · Received May 13, 2021

    Report

    Report Number
    3012447612-2021-00161
    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
    00880304865068
    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. D2: PRODUCT CODE: QHP. THE DEVICE WAS NOT RETURNED. 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 THIRTY EIGHT OF THIRTY NINE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719044 CORD 300MM THE TETHER - VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. N/A 3003482 00880304865068

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R