BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 2942974 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00319
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THREAD FLANKS OF THE LOCKING SCREW ARE PARTIALLY FLATTENED AND AT THESE DAMAGES THE ANODIZATION LAYER IS WORN OUT. THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGED THREAD FLANKS. THAT AT THE DAMAGES TO ANODIZATION LAYER IS WORN OUT DOES INDICATE THAT THE DAMAGE WAS CAUSED POST-MANUFACTURING BY AN EXCESSIVE CONTACT WITH THE IMPLANT, PAR EXAMPLE BY AN UNDUE ANGLE DURING THE SCREW INSERTION. BASED ON THE COMPLAINT DESCRIPTION AND THE DESIGN OF THE ZERO-P CONSTRUCT, THE SCREWS DID NOT CONTRIBUTE TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL FUSION AT C6-7 WITH ZERO-P PROCEDURE, IT WAS REPORTED THE ZERO-P IMPLANT BROKE BETWEEN THE PEEK SPACER AND THE TITANIUM INTERFACE. AS THE SURGEON WAS PUTTING THE SCREWS IN, HE NOTICED THE IMPLANT WAS WOBBLY. WHEN THE SURGEON BACKED OUT THE SCREWS, THE TITANIUM PIECE CAME OUT WITH THE SCREWS AND THE PEEK SPACER STAYED IN THE PATIENT. ONCE HE TOOK EVERYTHING OUT, THE SURGEON CHANGED THE SURGERY TO A STAND ALONE VERTEBRAL BODY SPACER CR AND A VECTRA PLATE. SURGERY WAS PROLONGED APPROXIMATELY A HALF AN HOUR. THE SURGEON WAS CONCERNED ABOUT THE PEEK PART OF THE IMPLANT BEING UP AGAINST THE CORD BUT HE DID NOT THINK THERE WAS PRESSURE PLACED THERE. NO ADDITIONAL INFORMATION WAS KNOWN POST SURGERY. THE IMPLANT WAS INTACT WHEN INITIALLY PLACED. THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49097 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM LOCKING SCREW OVE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention