BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3003421 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-10910
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 26, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    LEGAL REPORTED PATIENT IMPLANTED WITH SYNEX II REPORTED: PATIENT RECEIVED A RECALL LETTER ON OCTOBER 28, 2010 THAT STATES THAT THERE WAS NO EVIDENCE OF FAILURE ON YOUR LAST VISIT AND THAT HE DID NOT APPEAR FOR A (B)(6) 2010, APPOINTMENT AND RECOMMENDS HE RETURN TO THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86989 NONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1