BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LCP VOLAR COLUMN DISTAL RADIUS PL 8H HEAD/4H SHAI

    MDR report key: 2221592 · Received August 19, 2011

    Report

    Report Number
    3003506883-2011-00516
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    July 26, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K091644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(6), INDICATES THE PT WAS IMPLANTED ON (B)(6) 2011 FOR A LEFT DISTAL RADIUS FRACTURE. X-RAY TAKEN ON (B)(6) 2011 SHOWED THE PLATE TO BE BROKEN. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2011 FOR REMOVAL OF THE BROKEN PLATE AND STABILIZATION WITH AN EXTERNAL FIXATION DEVICE. THIS IS THE FIRST OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LCP VOLAR COLUMN DISTAL RADIUS PL 8H HEAD/4H SHAI : TI LCP VOLAR COLUMN DISTAL RADIUS PLATE HRS SYNTHES ELMIRA 5766170

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCREW