BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L24 TAN

    MDR report key: 3231241 · Received July 17, 2013

    Report

    Report Number
    2520274-2013-04238
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K071184
    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. 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. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS (B)(4). POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDED KNOWN IMPLANT DATE. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    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 5 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. TWENTY-FIRST 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
    330587 VA LOCKSCR Ø2.4 SELF-TAP L24 TAN HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention