BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DVR PLATE

    MDR report key: 6795843 · Received August 15, 2017

    Report

    Report Number
    0001825034-2017-06370
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    June 13, 2015
    Report Date
    August 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KTT
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERAPY DATE: (B)(6) 2015. REPORT SOURCE. LITERATURE - NAOHIDE TAKEUCHI, SHUNSUKE HOTOKEZAKA, TAKAMITSU OKADA, HIDEHIKO YUGE, TAKAO MAE & YUKIHIDE IWAMOTO (2015) RECOVERY OF WRIST FUNCTION AFTER VOLAR LOCKING PLATE FIXATION FOR DISTAL RADIUS FRACTURES. THE JOURNAL OF HAND SURGERY (ASIAN-PACIFIC VOLUME) 2016;21(2):199-206. HTTP://WWW.WORLDSCIENTIFIC.COM/DOI/ABS/10.1142/S2424835516500193?JOURNALCODE=JHS. 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 WAS ONE PATIENT REQUIRED REMOVAL OF IMPLANTS WITH RELEASE OF CARPAL TUNNEL DUE TO MEDIAN NERVE DISTURBANCE THAT OCCURRED COINCIDENT WITH BIOMET VOLAR LOCKING PLATE, DVR ANATOMIC PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574182 UNKNOWN DVR PLATE PROSTHESIS, WRIST KTT BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other