BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03624

    MDR report key: 3183115 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03624
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    September 2, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMPS STARTED TO GET LOOSE. CLAMPS AND DISPOFIX, WERE LOOSEN, AND FIXATION WAS REATTEMPTED USING DISPOFIX IN (B)(6) 2011. IN THE OPERATION ONLY THE FRAME WAS EXCHANGED TO REDUCE AND STABILIZE THE FRACTURE. ONE WEEK LATER, ONE OF THE CLAMPS HAD TO BE REFASTENED REPEATEDLY OVER TIME. FURTHER, OTHER CLAMPS IN THE SYSTEM STARTED LOOSENING, WHICH CAUSED DIFFICULTY TO RETAIN THE FRACTURE REDUCING POSITION. ALTHOUGH THE DISPO-FIX WAS USED MORE THAN ONE MONTH, IT WAS REMOVED AT THE SECOND WEEK OF OCTOBER, AFTER INFECTION WAS FOUND AT THE CELL DRILL INSERTION AREA. BONE UNION HAD NOT YET BEEN COMPLETED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283556 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention