BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P LORDOTIC H6 PEEK

    MDR report key: 3160774 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-02307
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    January 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. ADDITIONAL EVALUATION FOUND THAT ALL MEASURABLE DIMENSIONS WERE VERIFIED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND "AOASIF" SPECIFICATIONS. THIS ARTICLE WAS MANUFACTURED IN SEPTEMBER 2009 ACCORDING TO THE SPECIFICATIONS. THE EVALUATION WAS NOT ABLE TO DETERMINE AN EXACT CAUSE FOR THE REPORTED SEPARATION OF THE ZERO-P IMPLANT.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION, WHEN THE SURGEON STARTS TO IMPACT THE IMPLANT AND TO PUT IN THE SPACER, THE PLATE GOT LOOSE FROM THE CAGE. THE SURGEON HAS NEVER SEEN THAT AND DECIDED TO IMPLANT ANOTHER ONE. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260924 ZERO-P LORDOTIC H6 PEEK OVE SYNTHES GMBH 3245313

    Patients

    Seq Age Sex Outcome Treatment
    1