BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM CONDYLAR PLATE 8 HOLES/57MM-RIGHT

    MDR report key: 3193496 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03674
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K001941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE PROVIDED LOT # 2718235 WAS NOT A VALID SYNTHES LOT NUMBER FOR CATALOG # 249.916. NO ADDITIONAL INFORMATION IS AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND AN INVALID LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT FELL FROM A HORSE ON (B)(6) 2012 AND WAS IMPLANTED WITH PLATES AND SCREWS ON (B)(6) 2012. PATIENT RETURNED TO SURGEON ON AN UNKNOWN DATE COMPLAINING OF PAIN. ON (B)(6) 2013 PATIENT RETURNED TO THE OR FOR REMOVAL OF 2 PLATES AND 15 SCREWS. IT IS NOT KNOWN IF PATIENT WAS REVISED TO ANY OTHER HARDWARE. THIS IS 2 OF 17 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293501 2.4MM CONDYLAR PLATE 8 HOLES/57MM-RIGHT HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention