BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET DVR-A PLATE

    MDR report key: 6794077 · Received August 15, 2017

    Report

    Report Number
    0001825034-2017-06317
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    January 4, 2013
    Report Date
    August 14, 2017
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HRS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). J. LOVERIDGE, N. AHEARN, C. GEE, D. PEARSON, S. SIVALOGANATHAN AND R. BHATIA. ¿TREATMENT OF DISTAL RADIAL FRACTURES WITH THE DVR-A PLATE ¿THE EARLY BRISTOL EXPERIENCE¿. HAND SURGERY, VOL. 18, NO. 2 (2013) 159-167. HTTP://DX.DOI.ORG/10.1142/S0218810413500184. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THERE WAS ONE (1) CASE OF INADEQUATE REDUCTION REQUIRING REVISION OF THE PLATE AS A POSTOPERATIVE COMPLICATION FOLLOWING A DISTAL VOLAR RADIUS TRAUMA PLATING PROCEDURE. THIS PATIENT WENT ON TO ACHIEVE SATISFACTORY RADIOLOGICAL PARAMETERS AND CLINICAL OUTCOME FOLLOWING REVISION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575770 UNKNOWN BIOMET DVR-A PLATE FIXATION, PLATE HRS BIOMET TRAUMA N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R