BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LCP ULNA OSTEOTOMY PLATE 6 HOLES

    MDR report key: 3881338 · Received June 18, 2014

    Report

    Report Number
    3006126083-2014-10010
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES RARON
    Product Code
    HRS
    PMA / PMN Number
    PK113364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IT IS UNKNOWN WHICH OF THE TWO LOT NUMBERS WERE INVOLVED IN THE COMPLAINED EVENT. REVIEWS OF THE DEVICE HISTORY RECORDS FOR BOTH LOTS WERE COMPLETED: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION OF EITHER LOT. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION FOR EITHER LOT. 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 FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS TREATED FOR AN ULNA FRACTURE WITH PLATE AND SCREW FIXATION. SIX WEEKS LATER EVERYTHING WAS FINE. HOWEVER, SIX MONTHS LATER ON (B)(6) 2014 PSEUDOARTHROSIS WAS DISCOVERED. THE HARDWARE WAS REMOVED ON (B)(6) 2014 AND WAS DISCARDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357025 2.7MM LCP ULNA OSTEOTOMY PLATE 6 HOLES PLATE, FIXATION, BONE HRS SYNTHES RARON

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention