BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P CONVEX H6 PEEK

    MDR report key: 2903544 · Received January 9, 2013

    Report

    Report Number
    8030965-2013-00075
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT IN QUESTION WAS FORWARDED TO THE PD AND HE DID PERFORM A FUNCTION TEST, WHICH HAS SHOWN THAT THE ZERO-P IS FUNCTIONAL AS REQUIRED. IT WAS POSSIBLE TO DISASSEMBLE AND ASSEMBLE THE COMPONENTS AS DESIGNED. AFTER ASSEMBLING THE TITANIUM PART DOES HOLD IN POSITION AND CAN ONLY BE REMOVED WITH EFFORT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND CAN ONLY ASSUME THAT APPLIED BENDING AND/OR TORSIONAL FORCES DURING THE INSERTION CAUSED THIS SEPARATING OF THIS IMPLANT. ANOTHER POSSIBLE REASON WOULD BE TOO HIGH LATERAL STRESS WHILE THE IMPLANT HOLDER WAS REMOVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    AN ACCOUNT IN (B)(6) REPORTED THE SURGEON HAD ISSUES WITH A ZERO-P IMPLANT COMING APART WHILE TRYING TO IMPLANT IT IN A PATIENT. THE SURGEON HAD FILLED THE LUMEN OF THE IMPLANT WITH VITOS BONE SUBSTITUTE AND AFTER PLACEMENT USING THE IMPLANT HOLDER HE NOTICED THE PLATE HAD SEPARATED FROM THE CAGE. THE SURGEON PUT IT BACK TOGETHER AND AGAIN IT CAME APART. THE SURGEON ATTEMPTED TO PLACE THE IMPLANT 4 TIMES. THE SURGEON THEN REQUESTED A NEW IMPLANT AS HE WAS NOT COMFORTABLE PLACING THE DAMAGED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12538 ZERO-P CONVEX H6 PEEK ZERO-P CONVEX H6 PEEK OVE SYNTHES GMBH 7787769

    Patients

    Seq Age Sex Outcome Treatment
    1