BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP RECONSTRUCTION PLATE6 HOLES/84MM

    MDR report key: 3173038 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03292
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANTED DATE WITHIN LAST 6 MONTHS. EXPLANTED DATE (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH GALEAZZI FRACTURE OF THE ARM, RADIUS, AND RADIAL JOINT WAS OUT OF PLACE AND MAL REDUCED. STANDARD TREATMENT WOULD BE TO PUT THE PLATE ON THE VOLAR ASPECT OF THE RADIUS BUT THE PLATE WAS PLACED ON THE DORSAL ASPECT OF THE RADIUS, AND PATIENT EXPERIENCED TENDON RUPTURE. REVISION INCLUDED REMOVING THE PLATE, PERFORMING A RADIAL OSTEOTOMY AND A TENDON TRANSFER. PLATED THE VOLAR ASPECT OF THE RADIUS COMBINED WITH THE DRUJ ARTHRODESIS AND THEN PERFORMED AN OSTEOTOMY OF THE ULNA. ALSO PERFORMED AN AUTOGRAPH FROM THE LILAC CREST TO THE AREA OF THE ULNA OSTEOTOMY. THE SURGICAL CONCLUSION WAS FAVORABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274002 3.5MM LCP RECONSTRUCTION PLATE6 HOLES/84MM KTT SYNTHES GMBH 3438793

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention