BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6083229 · Received November 7, 2016

    Report

    Report Number
    2520274-2016-15262
    Event Type
    Injury
    Date Received
    November 7, 2016
    Report Date
    October 17, 2016
    Manufacturer
    SYNTHES, USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR ONE (1) UNKNOWN VARIATION ANGLE PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR ONE (1) UNKNOWN VARIATION ANGLE PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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 ON (B)(6) 2016, A PATIENT UNDERWENT A PLANNED REVISION SURGERY TO REMOVE A VARIABLE ANGLE ELBOW PLATE AND AN UNKNOWN NUMBER OF SCREWS DUE TO THE DELAYED HEALING AND LACK OF WOUND CLOSURE. IT WAS REPORTED THAT THE BONE HAD HEALED. THE SURGEON OPTED TO REMOVE THE PLATE AND SCREWS AS HE FELT THE WOUND MAY HEAL BETTER WITH THE PLATE AND SCREWS BEING EXPLANTED. THE DEVICES, IMPLANTED ON AN UNKNOWN DATE, WERE REMOVED INTACT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAYS AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE POST-OPERATIVE STATUS OF THE PATIENT IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN VARIATION ANGLE PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732933 PLATE, FIXATION, BONE HRS SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention