BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57

    MDR report key: 2220317 · Received August 5, 2011

    Report

    Report Number
    3003506883-2011-00508
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SERVICE. 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: PATIENT 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 PATIENT'S ARM. PATIENT WAS RETURNED TO THE OPERATING ROOM OF A DIFFERENT HOSPITAL FOR REMOVAL OF THE BROKEN PLATE AND WAS REVISED TO A DIFFERENT PLATE AND SCREWS ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LCP ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57 TI LCP ONE-THIRD TUBULAR PLATE HRS SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW