BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 2981479 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-00643
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE SCREW APPEARS TO BE USED. THE SCREW LACKS ANODIZATION ON MOST OF TAPERED THREADS. TWO SCRATCHES EXIST PERPENDICULAR TO THE TAPERED THREADS. THE DRIVER ENGAGEMENT SURFACES POSSESS SCRATCHES BUT NO MATERIAL DEFORMATIONS. THE RELEVANT DIMENSIONS OF THE LOCKING THREAD CAN NOT BE VERIFIED ANYMORE BECAUSE THE THREAD FLANKS ARE COMPLETELY FLATTENED, WHICH CAN HAVE AN INFLUENCE ON THE LOCKING FUNCTION OF THE SCREW. IT IS CLEARLY VISIBLE AT THE DAMAGE THAT THE ANODIZATION LAYER IS WORN OUT, WHICH INDICATES THAT THE DAMAGE WAS CAUSED POST-MANUFACTURING, EITHER DURING THE INSERTION, IN SITU OR EXTRACTION. THIS SCREW IS MEMBER OF A FAMILY OF THREE SPINE LOCKING SCREWS FOR THE ZERO-P SYSTEM. THE ENGINEER REVIEWED THE DRAWING. THE WORN ANODIZATION ON THE TAPERED THREADS SUGGESTS THE SCREW ENGAGED THE PLATE. THE ENGINEER REVIEWED THE RISK ASSESSMENT FOR THIS IMPLANT. THIS DOCUMENT ADEQUATELY ADDRESSES THE HAZARD OF THIS COMPLAINT. THERE IS NO EVIDENCE OR DETAIL IN THE COMPLAINT DESCRIPTION TO POSITIVELY INDICATE THE ROOT CAUSE OF THIS HAZARD.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT WAS IMPLANTED WITH A TI CERVICAL SPINE LOCKING SCREW. ON AN UNKNOWN DATE THE PATIENT FELL. THE SURGEON BELIEVED THE FALL CAUSED THE CERVICAL LOCKING SCREW TO BACK OUT OF THE PLATE. ON (B)(6) 2013 THE SURGEON REMOVED THE SCREW FROM C5-6 INTERBODY PLATE. THE SURGEON COULD SEE DAMAGE ON THE ZERO-P SCREW THREADS. THE SCREW WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85491 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention