BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3915682 · Received July 7, 2014

    Report

    Report Number
    2520274-2014-11863
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WHITE, B., ET. AL., (2012), INCIDENCE AND CLINICAL OUTCOMES OF TENDON RUPTURE FOLLOWING DISTAL RADIUS FRACTURE, JOURNAL OF HAND SURGERY, 37, 2035-2040. THIS ARTICLE EVALUATED THE INCIDENCE OF TENDON RUPTURE AFTER NON-OPERATIVE AND OPERATIVE MANAGEMENT OF DISTAL RADIUS FRACTURES, REPORT CLINICAL OUTCOMES AFTER TENDON REPAIR OR TRANSFER, AND EXAMINE VOLAR PLATE AND DORSAL SCREW PROMINENCE AS A PREDICTOR OF TENDON RUPTURE. A RETROSPECTIVE CHART REVIEW ON PATIENTS TREATED FOR TENDON RUPTURE AFTER DISTAL RADIUS FRACTURE. THERE WERE SIX TENDON RUPTURES IN 1,359 PATIENTS TREATED NON-OPERATIVELY AND EIGHT TENDON RUPTURES IN 999 PATIENTS TREATED WITH VOLAR PLATE FIXATION. THERE WERE MULTIPLE DEVICE COMPANIES THAT CONTRIBUTED TO TENDON RUPTURE HOWEVER, ONLY ONE PATIENT OUT OF THE EIGHT RECEIVED A 2.4MM EXTRA-ARTICULAR VOLAR LOCKING PLATE, SYNTHES, THAT HAD TENDON RUPTURE. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS COMPLAINT INVOLVES AN UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393907 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention