BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 4017478 · Received August 18, 2014

    Report

    Report Number
    1719045-2014-10391
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 24, 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

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: PIONEER SURGICAL TECHNOLOGY MANUFACTURED THE CABLE TENSIONER, PART NUMBER 391.201, AND LOT NUMBER P141349. DUE TO AN UNKNOWN CAUSE, THE TENSIONER FAILED IN TIGHTENING UP DURING SURGERY. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE AND THE SYNTHES FINAL INSPECTION SHEET. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS NOT MANUFACTURING-RELATED AND IS CONSIDERED UNCONFIRMED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT/EXPLANT DATE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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: IT WAS REPORTED THE CABLE TENSIONER FAILED TO TIGHTEN DURING SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494882 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P141349

    Patients

    Seq Age Sex Outcome Treatment
    1