BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL-STERILE

    MDR report key: 3031801 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10636
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 7, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED WITH CATCH MECHANISM ON THE CRANIAL SIDE OF THE PLATE STUCK. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT EVALUATION REVEALS THAT MEASUREMENT OF THE RELEVANT DIMENSIONS WERE OUT OF SPECIFICATION. FROM A DESIGN STANDPOINT THIS COMPLAINT IS CONSIDERED INDETERMINATE. A CAPA RISK ASSESSMENT WAS COMPLETED FOR THE IDENTIFIED NON-CONFORMANCE. BASED ON THE RESULTS OF THIS RISK ASSESSMENT A CAPA WILL NOT BE INITIATED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 2-LEVEL ZERO-P VA PROCEDURE AT LEVELS C4-C5 AND C5-C6, THE SURGEON HAD INSERTED THE TRIAL, REMOVED IT, THEN PLACED THE ZERO-P IMPLANT, SIZE 7 AND INSERTED THE SCREW INTO THE IMPLANT AT LEVEL C4-C5. THE GOLD BLOCKING MECHANISM IN THE IMPLANT NEVER POPPED UP TO LOCK THE SCREW IN PLACE. THE SURGEON TIGHTENED THE SCREW DOWN A LITTLE MORE, TOOK FLUOROSCOPIC IMAGES TO CHECK THE ANGLE OF THE SCREW, WHICH WAS CORRECT. THE SURGEON NOTED THAT THE BLOCKING MECHANISM STILL HAD NOT POPPED UP AS IT SHOULD. THE SURGEON THEN REMOVED THE ENTIRE IMPLANT, REPLACED WITH ANOTHER SAME SIZE ZERO-P, AND REINSERTED THE ORIGINAL SCREWS, AND THE BLOCKING MECHANISM IN THE NEW IMPLANT FUNCTIONED PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133884 ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL-STERILE OVE SYNTHES GMBH 7706771

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR