BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5139574 · Received October 8, 2015

    Report

    Report Number
    2520274-2015-16509
    Event Type
    Injury
    Date Received
    October 8, 2015
    Report Date
    September 14, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK100776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS REPORT IS FOR ONE, UNKNOWN 2.4MM/2.7MM VARIABLE ANGLE (VA) LOCKING X-PLATES. THE REPORTED PART NUMBER 02.227.202 IS NOT A VALID SYNTHES PART NUMBER AND IS LIKELY PART NUMBER 02.211.202, 2.4/2.7MM VA-LOCKING X-PLATE SMALL, 510(K)--K100776, COMMON NAME--PLATE, FIXATION, BONE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE IN (B)(6) 2014 DUE TO A NON-UNION AND DELAYED HEALING. THE PATIENT INITIALLY WAS IMPLANTED WITH TWO, 2.4MM/2.7MM VARIABLE ANGLE (VA) LOCKING X-PLATES AND NINE SCREWS ON (B)(6) 2014. THE DETAILS FOR THE REVISION SURGERY ARE UNKNOWN. THIS REPORT IS FOR ONE, UNKNOWN 2.4MM/2.7MM VARIABLE ANGLE (VA) LOCKING X-PLATE. THIS REPORT IS 1 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667425 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention