BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP® VOLAR DISTAL RADIUS PLATEEXTRA-ARTICULAR 4H HEAD-LEFT

    MDR report key: 3132667 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02883
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K091644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH 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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DISTAL RADIUS PLATE WAS IMPLANTED ON (B)(6) 2012. POST-OPERATIVELY, ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE PATIENT REQUIRED A REVISION SURGERY. THE CAUSE OF REVISION WAS LACK OF REDUCTION DUE TO EARLY USE OF THE SURGICAL CORRECTED / NON-UNION WRIST FRACTURE. THE SURGEON REMOVED ALL EXISTING HARDWARE, RE-REDUCED THE FRACTURE AND RE-PLATED WITH SYNTHES PARTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236477 LCP® VOLAR DISTAL RADIUS PLATEEXTRA-ARTICULAR 4H HEAD-LEFT HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention