BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2971307 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-00570
    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

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE THREAD FLANKS BELOW THE SCREW HEAD ARE COMPLETELY FLATTENED. THE STARDRIVE RECESS IS DAMAGED AND THERE IS A CLEARLY VISIBLE THREAD SHAPED STRESS MARK AT THE SCREW HEAD. AT ALL DAMAGES, THE ANODIZATION LAYER IS WORN OUT, WHICH INDICATES THAT THE DAMAGE WAS CAUSED POST-MANUFACTURING. BASED ON THE APPEARANCE OF THE SCREW, WE SUPPOSE THAT THIS SCREW WAS INSERTED IN AN UNDUE ANGLE INTO THE IMPLANT. THIS WOULD CAUSE AN EXCESSIVE CONTACT BETWEEN THE SCREW AND THE IMPLANT AND THE DEFORMATION OF THE THREAD FLANKS AND WOULD EXPLAIN THE DAMAGE OF THE STARDRIVE RECESS AS HIGH FORCES WERE NEEDED DURING THE INSERTION. THE THREAD SHAPED STRESS MARK AT THE SCREW HEAD ALSO INDICATES AN EXCESSIVE CONTACT WITH THE IMPLANT AND LET US SUPPOSE THAT THE LOCKING MECHANISM DID NOT LOCK AT THIS SCREW BECAUSE OF AN EXCESSIVE INSERTION ANGLE DURING THE PROCEDURE. THE PERFORMED FUNCTION TEST HAS SHOWN THAT THE SCREW IS STILL LOCKED BY THE LOCKING MECHANISM WHEN IT IS MANUALLY INSERTED INTO THE IMPLANT. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    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 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76342 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 14MM CERVICAL SPINE SCREW OVE SYNTHES GMBH 8047998

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention