BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORD 300MM

    MDR report key: 10600291 · Received September 29, 2020

    Report

    Report Number
    3012447612-2020-00574
    Event Type
    Injury
    Date Received
    September 29, 2020
    Report Date
    October 27, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    QHP
    PMA / PMN Number
    H190005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A2: DATE OF BIRTH: UNKNOWN DAY IN (B)(6) OF 2007 A4: WEIGHT: 33.8 KG D4: UDI#: (B)(4). D11: CATALOG#: 211H6035 6.0MM DIA X 35MM VBT ASSY, LOT#: NI. CATALOG#: 211H6032 6.0MM DIA X 32.5MM VBT ASSY, LOT#: 2958624. CATALOG#: 302H0012, LOT#: 2958624. CATALOG#: 211H6030 6.0MM DIA X 30MM VBT ASSY, LOT#: 2958623. CATALOG#: 211H6025 6.0MM DIA X 25MM VBT ASSY, LOT#: 2970357. CATALOG#: 211H6027 6.0MM DIA X 27.5MM VBT ASSY, LOT#: 2958622. THE EVENT IS CONFIRMED WITH X-RAYS RECEIVED. VISUAL EXAMINATION OF THE X-RAYS CONFIRMED THAT THE CURVE OF THE PATIENT'S SPINE HAD EXCEEDED 38 DEGREES POST-OP. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. FOLLOWING THE INITIAL SURGERY, PATIENT CONDITION SHOULD HAVE STABILIZED OR IMPROVED. ALTHOUGH THERE IS NO CLEAR DEFECT WITH THE PART, THE PATIENT'S CONDITION DID NOT APPEAR TO IMPROVE. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WILL NEED A REVISION SURGERY AFTER THE THEIR CURVE BEGAN TO INCREASE 3 MONTHS POSTOPERATIVELY. A REVISION IS PLANNED, TO REMOVE AND RETIGHTEN THE CORD, BUT NOT SCHEDULED AT THIS TIME. NO FURTHER PATIENT OR SURGICAL INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    TYPE OF THE DEVICE: PRODUCT CODE: QHP. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WILL NEED A REVISION SURGERY AFTER THE THEIR CURVE BEGAN TO INCREASE 3 MONTHS POSTOPERATIVELY. A REVISION IS PLANNED, TO REMOVE AND RETIGHTEN THE CORD, BUT NOT SCHEDULED AT THIS TIME. NO FURTHER PATIENT OR SURGICAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063539 CORD 300MM THE TETHER- VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. NA 2966796

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R