BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P VA IMPLANT 10MM HEIGHT LORDOTIC-STERILE

    MDR report key: 2896676 · Received January 4, 2013

    Report

    Report Number
    8030965-2013-00026
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE RE-INSPECTION OF THE PART HAS SHOWN THAT THE INNER DIAMETER OF THE LOCKING MECHANISM HOLE IS OUT OF SPECIFICATION. THIS DEVIATION HAS AN INFLUENCE ON THE LOCKING MECHANISM. A CAPA DETERMINATION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE IMPLANT WAS RECEIVED AND REVIEWED UNDER MICROSCOPE. THE BLOCKER IN QUESTION WAS STUCK IN THE OPEN POSITION AND ROTATED APPROXIMATELY 25 DEGREES. THE IMPLANT DID NOT DISPLAY ANY OBVIOUS SIGNS OF MISUSE OR WEAR. THE CORNER OF THE BLOCKER WAS ENGAGED WITH ONE OF THE RETAINING SCREW THREADS. THE IMPLANT WAS DISASSEMBLED FOR FURTHER REVIEW AND INSPECTED USING PIN GAUGES AND A MICROMETER. THE 2.18 DIAMETER PIN WENT TO THE BOTTOM OF THE HOLE AND THE 2.20 PIN WENT 1/3 OF THE WAY TO THE HOLE IN THE HOLE WITH THE STUCK BLOCKER. IN THE OTHER HOLE, THE 2.2- DIAMETER PIN WENT TO THE BOTTOM OF THE HOLE AND THE 2.22 DIAMETER PIN WENT 1/4 OF THE WAY INTO THE HOLE. THE BLOCKER OUTSIDE DIAMETERS MEASURED 2.184MM. BOTH THE BORE IN THE PLATE WHICH MEASURED 2.18MM AT THE BASE AND THE BLOCKERS WERE OUT OF SPECIFICATION. AFTER INSPECTION THE PLATE WAS RE-ASSEMBLED WITH THE EXCEPTION OF THE SET SCREW AND A SCREWDRIVER WAS USED TO PUSH THE BLOCKER TO THE BASE OF THE BORE. AS A RESULT, THE BLOCKER BECAME WEDGED AGAIN. THE DESIGN HISTORY FILE INCLUDING THE FUNCTIONAL AND DESIGN REQUIREMENTS MATRIX AND THE RISK ANALYSIS WERE REVIEWED.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DURING AN ACDF SURGERY, THE SURGEON WAS USING A ZERO-P VA IMPLANT AND ONE OF THE BLOCKING MECHANISMS WAS STUCK AND WOULDN'T ENGAGE THE SCREW. THE SURGEON REMOVED THE IMPLANT AND IMPLANTED A ZERO-P IMPLANT WITHOUT A PROBLEM. THE SURGERY WAS DELAYED FOR APPROXIMATELY 3 TO 5 MINUTES AND THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4196 ZERO-P VA IMPLANT 10MM HEIGHT LORDOTIC-STERILE ZERO-P VA IMPLANT OVE SYNTHES GMBH 7706774

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR