BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.25MM CERCLAGE WIRE COILS 10 METERS

    MDR report key: 2922476 · Received January 18, 2013

    Report

    Report Number
    3003506883-2013-00033
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SYNTHES IS UNABLE TO DETERMINE 510(K) #. ADDITIONAL INFORMATION REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH CERCLAGE WIRE ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 FOR REMOVAL OF THE CERCLAGE WIRE DUE TO NON-UNION. IT IS UNKNOWN HOW THE NON-UNION WAS DETECTED. SURGEON REVISED PATIENT TO ORIF OF PATELLA. SURGEON WAS CONTOURING THE PLATE PRIOR TO INSERTION AND THE PLATE BROKE DURING THE REVISION SURGERY. SURGEON USED A DIFFERENT PLATE AND COMPLETED PROCEDURE WITH NO FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27217 1.25MM CERCLAGE WIRE COILS 10 METERS 1.25MM CERCLAGE WIRE JDQ SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention PLATE