BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO

    MDR report key: 3231261 · Received July 17, 2013

    Report

    Report Number
    8030965-2013-04302
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THE PLATE WAS RETURNED INTACT, NO DAMAGE VISIBLE. THE PLATE HAD NO EFFECT ON THE SCREWS FRACTURE.

    Description of Event or Problem · 1

    POST-OPERATIVELY, IT WAS DISCOVERED THAT THE VARIABLE ANGLE LOCKING COMPRESSION PLATE AND A TOTAL OF FIVE LOCKING SCREWS HAD THE HEADS BROKEN OFF IN THE PATIENT. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD A DISTAL RADIUS FRACTURE ON RIGHT SIDE CAUSED BY A FALL DURING A FOOTBALL MATCH. PATIENT IMPLANTED (B)(6) 2013 WITH PLATE AND SCREWS. FOLLOW UP X-RAY WAS PERFORMED (B)(6) 2013. 21ST DAY POST OP X-RAY WAS PERFORMED AND REMOVAL OF K-WIRE UNDER LOCAL ANESTHESIA, AND STARTED GRADUAL PHYSIOTHERAPY. REPORTEDLY ON (B)(6) 2013 THE BREAKAGE OF SCREWS AND RE-DISLOCATION WAS FOUND. ON (B)(6) 2013 THE IMPLANTS WERE REMOVED AND PATIENT WAS REVISED TO A NEW VA-TCP PLATE AND LARGE SCREWS WITH TEMPORARY FIXATION WITH K-WIRE AND APPLICATION OF A LONG PLASTER SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331511 VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO HRS SYNTHES GMBH 8010968

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention