BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01995

    MDR report key: 3061063 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-01995
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DATE OF IMPLANT WAS REPORTED AS (B)(6) 2013.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT FOR A DISTAL LEFT RADIUS FRACTURE ON AN UNKNOWN DATE IN (B)(6) 2013. DURING A ROUTINE POST-OPERATIVE OFFICE VISIT, A LOSS OF FIXATION OF THE LEFT DISTAL RADIUS PLATE WAS NOTED VIA X-RAY, DATE UNKNOWN. PATIENT ALSO COMPLAINED OF INCREASED PAIN. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH PERCUTANEOUS PINNING AND APPLICATION OF AN EXTERNAL FIXATOR AND ALLOGRAFT BONE. WHILE REMOVING THE PLATE, THE SURGEON NOTED THAT TWO SCREW HEADS HAD BROKEN OFF COMPLETELY. ALL PIECES WERE RETRIEVED. SURGERY WENT AS PLANNED. THIS REPORT IS FOR AN UNKNOWN CORTICAL SCREW. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162171 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention