BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK-L-PL-2 LE 5HO TI

    MDR report key: 3001374 · Received March 13, 2013

    Report

    Report Number
    8030965-2013-00831
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES VISUAL INSPECTIONS NOTED A LONG BURR. IT IS POSSIBLE THAT THE BURR WAS CAUSED DUE TO A WORN OUT MILLING TOOL. THIS FAILURE MAY HAVE OCCURRED THROUGH THE PROCESS OF CUTTING THE PLATE OFF THE BASE MATERIAL. AS A RESULT, THE TEST INSTRUCTIONS FOR VISUAL CONTROL HAS BEEN UPDATED. A DETERMINATION FOR AN INTERNAL CORRECTION ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THERE IS A BURR ON PLATE. IT WAS NOTICED BY THE DISTRIBUTION STAFF UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105139 LOCK-L-PL-2 LE 5HO TI JEY SYNTHES GMBH 8043553

    Patients

    Seq Age Sex Outcome Treatment
    1