BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-DEVICE F/SYNFIX-LR 13.5

    MDR report key: 2914210 · Received December 7, 2012

    Report

    Report Number
    8030965-2012-01506
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MFG DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATED TARGET FULFILLS ALL NECESSARY REQUIREMENTS. MOREOVER IT OBSERVES ALL SPECIFICATIONS. BASED ON THIS RESULT WE EXCLUDE A MANUFACTURING ERROR. WE ONLY ASSUME THAT DURING THE PROCEDURE OF RE-PROCESSING CYCLES THE FITTING CAME LOOSE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SCREWS OF THE COVER PLATE FOR THE AIMING DEVICE ARE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIM-DEVICE F/SYNFIX-LR 13.5 AIMING DEVICE LXH SYNTHES GMBH 2144914

    Patients

    Seq Age Sex Outcome Treatment
    1