BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5401724 · Received February 1, 2016

    Report

    Report Number
    2520274-2016-10608
    Event Type
    Injury
    Date Received
    February 1, 2016
    Report Date
    January 15, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE - HWC. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GREEN, D., HENDERSON, C., (2013), MODIFIED AO ARTHRODESIS OF THE WRIST (WITH PROXIMAL ROW CARPECTOMY), THE JOURNAL OF HAND SURGERY, 38(2), 388-391 (USA). FROM 1994 TO 2011, 110 WRISTS WERE ARTHRODESED. THE AGE RANGE OF THE PATIENTS IS FROM 19 TO 76 YEARS. A 9 HOLE TAPERED PLATE IN THE AO WRIST ARTHRODESIS SET WAS USED IN THIS SURGERY. COMPLICATIONS THAT WERE REPORTED ARE NONUNIONS. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO WRIST ARTHRODESIS SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59634 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention