BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2850020 · Received November 29, 2012

    Report

    Report Number
    8030965-2012-01394
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    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

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE HOLE VA2 IS NOT MEASURABLE, BECAUSE THIS HOLE GOT DAMAGED AFTER THE LOT RELEASE. THE OVERALL CONCLUSION TO THE PLATE: ALL INSPECTED CHARACTERISTICS ARE IN SPECIFICATION. WE CONCLUDE THAT THE CAUSE OF THIS DAMAGE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(4) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE, AFTER REPOSITIONING AND IMPLANTING THE PLATE, THE SURGEON THEN INSERTED THE CORTEX SCREW IN A POSITIONING HOLE AT THE SHAFT. WHILE THE SURGEON WAS INSERTING THE VA LOCKING SCREW INTO THE MOST DISTAL HOLE IN THE FIRST ROW AT THE ULNAR SIDE OF THE PLATE WITH THE TORQUE LIMITING DRIVER USING A GUIDING BLOCK BY A FIXED-ANGLE PROCEDURE, THE LOCKING SCREW WENT THROUGH THE PLATE. THIS EVENT WAS NOTED WHILE VIEWING THE X-RAY. THE SURGEON REMOVED THE PLATE AND SCREWS AND REPLACED THE PLATE WITH ANOTHER SIZED PLATE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 2HO PLATE HRS SYNTHES GMBH 7615062

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCREW