BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04613

    MDR report key: 3251240 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04613
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 2 UNKNOWN LOCKING SCREWS. 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 A PATIENT UNDERWENT SURGERY FOR A TRIMALLEOLAR ANKLE FRACTURE ON (B)(6) 2013. A CT SCAN TAKEN TWO WEEKS POST-OPERATIVE REVEALED A 3 MM STEP OFF OF THE DISTAL TIBIA JOINT SURFACE ON THE POSTERIOR MALLEOLUS FRAGMENT. A DECISION WAS MADE TO DO A REVISION SURGERY TO CORRECT THE JOINT SURFACE. ALL HARDWARE WAS REMOVED AND NEW HARDWARE WAS SUCCESSFULLY REIMPLANTED DURING THE REVISION SURGERY. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352667 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention