BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3355575 · Received September 18, 2013

    Report

    Report Number
    1719045-2013-01968
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Date of Event
    August 19, 2013
    Report Date
    August 20, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # 6611824 WAS COMPLETED. A NON CONFORMANCE REPORT WAS WRITTEN AGAINST THE LOT FOR THE MAJOR AND MINOR THREAD DIAMETERS BEING OUT OF TOLERANCE. THE LOT WAS 100% INSPECTED AND REWORKED. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. 81 PARTS WERE RELEASED TO THE WAREHOUSE ON 7/29/2011 AND 52 PARTS WERE RELEASED TO THE WAREHOUSE ON 9/12011. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLLOWING EVENT THAT OCCURRED DURING A POSTERIOR LUMBAR FUSION SURGERY. THE THREADS AT THE DISTAL TIP OF THE LONG HOLDING SLEEVE BEGAN TO UNCOIL OFF THE TIP OF THE SLEEVE, MAKING THE HOLDING SLEEVE NON-FUNCTIONAL. THE SURGEON USED A COMPETITORS SYSTEM INSTRUMENTATION TO COMPLETE THE CASE. THERE WERE NO REPORTED FRAGMENTS LEFT IN THE PATIENT AND SURGERY WAS EXTENDED BY APPROXIMATELY 15 MINUTES WHILE THE SURGEON WAITED FOR THE ALTERNATE INSTRUMENTATION TO COME UP FROM MATERIALS DEPARTMENT. THERE WAS NO REPORTED HARM TO THE PATIENT FOLLOWING THE PROCEDURE. THIS IS REPORT 2 OF 2 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469318 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6611824

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown