BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREW

    MDR report key: 2211313 · Received August 3, 2011

    Report

    Report Number
    2520274-2011-00534
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SVC. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A LEGAL CLAIM FROM (B)(6) REPORTED: PT INVOLVED IN (B)(6) WAS IMPLANTED ON (B)(6)-2008 WITH A TI LCP ONE-THIRD TUBULAR PLATE W/COLLAR. DURING THE REHABILITATION PROGRAM, AN X-RAY SHOWED THE PLATE WAS BROKEN AND CAUSED A SUB-FRACTURE ON THE PT'S ARM. PT WAS RETURNED TO THE OPERATING ROOM OF A DIFFERENT HOSP FOR REMOVAL OF THE BROKEN PLATE AND WAS REVISED TO A DIFFERENT PLATE AND SCREWS ON AN UNK DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - SCREW SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE