BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 3091367 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-00663
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED DURING A ZERO-P REVISION, WHILE TRYING TO TAKE OUT SCREWS, THE HANDLE BROKE. USED NEW HANDLE. WHEN USING THE SCREWDRIVER, THE INTERFACE BENT AND ANOTHER ONE WAS USED WHICH BENT AS WELL. THIRD SCREWDRIVER WORKED FINE. THERE WAS NO EXTENSION ON SURGERY TIME. THE REVISION WAS DUE TO THE PATIENT COMPLAINING OF PAIN. IT WAS DISCOVERED THAT OSTEOPHYTES HAD GROWN POSTERIORLY AS A RESULT FROM FIRST IMPLANT. IMPLANT DATE WAS IN 2009. THE IMPLANT SURGEON AND EXPLANT SURGEON ARE DIFFERENT. THIS IS REPORT # 4 OF 5 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193734 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention