BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/2H/LT/82MM-MED-STER

    MDR report key: 6182911 · Received December 16, 2016

    Report

    Report Number
    2520274-2016-15699
    Event Type
    Injury
    Date Received
    December 16, 2016
    Report Date
    November 25, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE HWC. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). 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 WAS 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT THE PATIENT HAD AN OPERATION AT ANOTHER HOSPITAL, AND TRANSFERRED TO THE COMPLAINANT. PATIENT EXPERIENCED RADIAL NERVE INJURY WHICH REQUIRED ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE HARDWARE. THE SURGEON EXFOLIATED IMMEDIATELY AND EXTRACTION WAS COMPLETED. TWO VA LCP (VARIABLE ANGLE LOCKING COMPRESSION PLATE) PLATE HAD BEEN USED FOR DISTAL HUMERUS. A CORTICAL SCREW HAD BEEN USED IN THE SECOND PROXIMAL HOLE OF INWARD PLATE, AND THE SCREW WAS INVOLVED IN RADIAL NERVE. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME. THE RE-SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) VA LCP PLATE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832612 2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/2H/LT/82MM-MED-STER PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention