BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P CONVEX H6 PEEK

    MDR report key: 3192652 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03479
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRESENT IMPLANT WAS CHECKED FOR CONFORMANCE TO PRINT SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. BASED ON THE DHR REVIEW, THE EVALUATION, AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ITEM CAME APART WHEN THE IMPLANT SHOULD BE USED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292618 ZERO-P CONVEX H6 PEEK OVE SYNTHES GMBH 3349117

    Patients

    Seq Age Sex Outcome Treatment
    1