BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DVR PLATE

    MDR report key: 6794539 · Received August 15, 2017

    Report

    Report Number
    0001825034-2017-06361
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    July 25, 2014
    Report Date
    August 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWJ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERAPY DATE: (B)(6) 2014. REPORT SOURCE, LITERATURE - LUIGI TARALLO, RAFFAELE MUGNAI, ROBERTO ADANI & FABIO CATANI (2014) MALUNITED EXTRA-ARTICULAR DISTAL RADIUS FRACTURES: CORRECTIVE OSTEOTOMIES USING VOLAR LOCKING PLATE. J ORTHOPAED TRAUMATOL (2014) 15:285-290. HTTPS://RD.SPRINGER.COM/CONTENT/PDF/10.1007%2FS10195-014-0307-X.PDF REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 THERE WERE TWO CASES OF TRANSIENT MEDIAN NEUROAPRAXIA THAT RESOLVED BEFORE THE 6-WEEK FOLLOW-UP APPOINTMENT. PATIENTS HAD PREVIOUSLY UNDERGONE CORRECTIVE OSTEOTOMY USING A VOLAR LOCKING PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575421 UNKNOWN DVR PLATE PROSTHESIS, WRIST JWJ BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other