BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP VOLAR COLUMN DISTAL RADIUS PL 9H HEAD/3H SHAFT/RT

    MDR report key: 2892819 · Received January 2, 2013

    Report

    Report Number
    3003506883-2012-00419
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K091644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. HOWEVER, A REVIEW OF THE RECORDS SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IMPLANT DATE REPORTED AS (B)(6) 2009.

    Description of Event or Problem · 1

    DURING A SURGERY IN (B)(6) 2009, A PATIENT WAS IMPLANTED HARDWARE TO REPAIR A WRIST FRACTURE. IN A LATER SURGERY ON (B)(6) 2012 TO CORRECT ULNAR SIDE PAIN, THE HARDWARE WAS TO BE REMOVED. DURING THE EXTRACTION, A SCREW HEAD BROKE OFF THE SCREW. THE SCREW HEAD WAS RETRIEVED BY THE PHYSICIAN AND THE PROCEDURE WAS DELAYED BY 4 TO 5 MINUTES. THIS IS 1 OF 12 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787 TI LCP VOLAR COLUMN DISTAL RADIUS PL 9H HEAD/3H SHAFT/RT COLUMN HRS SYNTHES ELMIRA 5662276

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SCREWS