BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3911586 · Received July 3, 2014

    Report

    Report Number
    1719045-2014-10288
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 REVEALED NO COMPLAINT RELATED ANOMALIES. ADDITIONAL RELEASE TO WAREHOUSE DATE: (B)(4) 2011. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: PIONEER SURGICAL MANUFACTURED THE CABLE TENSIONER AND COMPLETED THE EVALUATION. THE EVALUATIONS FOUND: VISUAL INSPECTION FOUND THE DEVICE TO BE FREE FROM DAMAGE OR DEBRIS WHICH COULD NEGATIVELY AFFECT THE PERFORMANCE OF THE DEVICE. THE DEVICE WAS TESTED AND FOUND THAT ALL TEST RESULTS MEET SPECIFICATIONS. DEVICE HISTORY RECORDS REVIEW CONFIRMED THIS PRODUCT MET SPECIFICATION PRIOR TO SHIPPING. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY PIONEER SURGICAL AND SYNTHES, THE COMPLAINT CONDITION IS UNCONFIRMED. UPON EVALUATION, THE DEVICE FUNCTIONED AS INTENDED; NO PRODUCT FAULT COULD BE DETECTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TENSIONER FAILED IN FUNCTION DURING SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391632 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P099483

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR