BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DNP PLATE

    MDR report key: 6797358 · Received August 16, 2017

    Report

    Report Number
    0001825034-2017-06393
    Event Type
    Injury
    Date Received
    August 16, 2017
    Report Date
    September 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERAPY DATE: (B)(6) 2015. REPORT SOURCE, LITERATURE - OMER KARATOPRAK, SINAN KARACA, MEHMET NURI ERDEM, FERIT KIRAC, MERIC ENERCAN & SERDAR TUNCER (2015) DORSAL NAIL PLATE VERSUS PERCUTANEOUS K-WIRE FIXATION IN THE TREATMENT OF DISPLACED DISTAL RADIUS FRACTURES. ACTA ORTHOP. BELG., 2015, 81, 65-71. HTTPS://PDFS.SEMANTICSCHOLAR.ORG/A25A/9AF156F0E33232D50A6E9608C3F329AA31B8.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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT REPORTED IS THAT ONE PATIENT IN THE PKW GROUP WAS TREATED WITH ORAL ANTIBIOTICS FOR PIN SITE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576670 UNKNOWN DNP PLATE PROSTHESIS, TRAUMA HRS BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other