BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 14MM

    MDR report key: 2971315 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-00569
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NO VISIBLE DAMAGES, EXCEPT SOME SLIGHT STRESS MARKS AT THE SCREW HEAD, WHICH WERE CAUSED DURING THE INSERTION. A FUNCTION TEST WAS PERFORMED AND THE SCREW DID LOCK IN PLACE IN THE IMPLANT AS REQUIRED. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. AFTER ASSEMBLING THE 2 SCREWS INTO THE IMPLANT, IT WAS NOTED THAT THE BLOCKING MECHANISM IS IN GOOD WORKING CONDITION. THERE DOES NOT SEEM TO BE ANY DESIGN RELATED ISSUES WITH THIS IMPLANT. IT IS POSSIBLE THAT EITHER SOFT TISSUE WAS INTERFERING WITH THE SCREW INSERTION AND/OR BLOCKING MECHANISM OR POSSIBLY IMPROPER SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    DURING A ACDF C6, C7 SPINE SURGERY, SURGEON INSERTED 2 SCREWS INTO THE INTERBODY PLATE OF THE ZERO P IMPLANT AND THE SECURING MECHANISM WOULD NOT ENGAGE ON ONE OF THE SCREWS. SURGEON REMOVED BOTH SCREWS AND PLATE PER SYNTHES TECHNIQUE GUIDE. SURGEON CHOSE ANOTHER SAME SIZE PLATE AND 2 LONGER LENGTH SCREWS TO IMPLANT. DUE TO THE REMOVAL AND IMPLANTING OF THE PLATE AND SCREWS, SURGERY WAS EXTENDED AN EXTRA 15 MINUTES. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76709 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 14MM CERVICAL SPINE SCREW OVE SYNTHES GMBH 7984093

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention