BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03631

    MDR report key: 3181272 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03631
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT HAS BEEN FOUND THAT MFR #2520274-2013-03681 (CATSWEB COMPLAINT (B)(4)) IS A DUPLICATE OF MFR #1719045-2010-00104 (NET REGULUS COMPLAINT (B)(4)). THEREFORE, MFR #2520274-2013-03681 IS BEING CANCELLED AND MFR #1719045-2010-00104 WILL REMAIN THE OFFICIAL CASE OF RECORD. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZERO-P IMPLANT SUBSIDED INTO THE INFERIOR VERTEBRAL BODY CAUSING AN UNKNOWN NUMBER OF SCREWS TO BACK OUT OF THE DEVICE. ON AN UNKNOWN DATE, THE PATIENT WAS TAKEN BACK TO SURGERY FOR REVISION TO A CERVICAL FIXATION CAGE. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282294 OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention