BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/7H HD/5H SHAFT/LT

    MDR report key: 3924851 · Received July 10, 2014

    Report

    Report Number
    2520274-2014-12080
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    December 11, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK110125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT POSTOPERATIVELY FOR AN OPEN REDUCTION INTERNAL FIXATION OF THE DISTAL RADIUS THE PATIENT EXPERIENCED TENDON RUPTURES OVER THE VARIABLE ANGLE VOLAR RIM DISTAL RADIUS PLATES. THE SURGEON REPORTED THIS HAS HAPPENED WITH THREE DIFFERENT PATIENTS THAT HAVE ALL BEEN SITTING IN GOOD POSITION WITH NO BACKING OUT OF THE SCREWS. THE DEVICE WILL NOT BE RETURNED. THIS REPORT IS FOR PATIENT NUMBER TWO. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403205 2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/7H HD/5H SHAFT/LT PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention