BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATOR MALLET

    MDR report key: 6010883 · Received October 7, 2016

    Report

    Report Number
    2523190-2016-00165
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    September 14, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    LXM
    PMA / PMN Number
    K950646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2016. THE INVESTIGATION INCLUDED: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. THE RETURNED INTEGRATOR SHOWING WEARS, REPAIR MARKINGS AND A BROKEN CENTER SCREW. THE INTEGRATOR WAS MANUALLY TESTED AND THE CENTER SCREW IS BROKEN AND DOES NOT FUNCTION AS DESIGNED. THE COMPLAINT IS CONFIRMED; UNSUCCESSFUL REPAIR NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. COMPLAINTS METRICS TRACKED, TRENDED, AND REVIEWED MONTHLY WITH MANAGEMENT. THERE WAS ONE INTERGRATOR MALLET REPAIRED (B)(6) 2016 RETURNED USED/PROCESSED SHOWING WEARS, REPAIR MARKINGS AND A BROKEN CENTER SCREW. THE COMPLAINT REPORT HAS BEEN CONFIRMED AS A REPAIR ISSUE; WE HAVE TAKEN MEASURES TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTEGRATOR MALLET IS NOT COCKING AFTER BEING REPAIRED FOR THE SAME FAILURE SIX DAYS EARLIER. PRODUCT WAS IN CONTACT WITH THE PATIENT HOWEVER, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662192 INTEGRATOR MALLET M54 - ORAL SURGERY LXM INTEGRA YORK, PA INC. 1606R (1789)

    Patients

    Seq Age Sex Outcome Treatment
    1