BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P IMPLANT 7MM HEIGHT

    MDR report key: 1903448 · Received November 15, 2010

    Report

    Report Number
    1719045-2010-00334
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    October 21, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    ODP
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE HAS NOT BEEN EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST IMPLANTATION TWO ZERO-P LEVELS C3-C5, RETURNED TO SURGEON FOR POST OP VISIT. AN X-RAY SHOWED A VERTEBRAL FRACTURE BETWEEN THE TWO IMPLANTED ZERO-P IMPLANTS AT C4. SURGEON NOTED THE PATIENT HAD OSTEOPENIC BONE, IMPLANTS ARE NOT BROKEN, AND THE IMPLANTATION WENT WELL AND LOOKED OK. IT IS NOT KNOWN IF THE VERTEBRAL BODY WAS FRACTURED DURING INSERTION OF THE IMPLANTS OR POST OPERATIVELY. SURGEON IS NOT REMOVING THE HARDWARE AT THIS POINT AND WILL MONITOR THE PATIENT. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO-P IMPLANT 7MM HEIGHT ZERO-P IMPLANTS ODP SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCREW