BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DVR PLATE

    MDR report key: 6795813 · Received August 15, 2017

    Report

    Report Number
    0001825034-2017-06389
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    November 15, 2010
    Report Date
    September 19, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERAPY DATE: (B)(6) 2010. REPOT SOURCE, LITERATURE - J. CHAPPUIS, P. BOUTE & P. PUTZ (2010) DORSALLY DISPLACED EXTRA-ARTICULAR DISTAL RADIUS FRACTURES FIXATIO: DORSAL IM NAILING VERSUS VOLAR PLATING. A RANDOMIZED CONTROLLED TRIAL. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2011) 97, 471¿478. HTTP://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S187705681100096X. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF THIS REPORT - (B)(6) 2017 CONCOMITANT MEDICAL PRODUCTS - UNK, UNKNOWN DNP PLATE, UNK (B)(4). DATE RECEIVED BY MANUFACTURER - AUG 25, 2017 TYPE OF REPORT - FOLLOW-UP 1 IF FOLLOW-UP, WHAT TYPE - ADDITIONAL INFORMATION, CORRECTION. THE FOLLOWING SECTIONS WERE CORRECTED: COMMON DEVICE NAME - FIXATION, PLATE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07200 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 THAT THREE PATIENTS HAD ALGODYSTROPHY. CLINICAL & RADIOGRAPHIC RESULTS WERE ANALYZED THE EARLY POSTOPERATIVE PERIOD AND AT 6-MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574178 UNKNOWN DVR PLATE FIXATION, PLATE KTT BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other