BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ. 20 PROXIMAL

    MDR report key: 5074646 · Received September 14, 2015

    Report

    Report Number
    1651501-2015-00033
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Report Date
    August 19, 2015
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    OMX
    PMA / PMN Number
    H010005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 23 OCT 2015. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE. -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: DEVICE HISTORY RECORD REVIEWED. THE REVIEW DID NOT IDENTIFY A NONCONFORMANCE RELATED TO THE COMPLAINT. A REVIEW OF COMPLAINTS FOR PIP IMPLANT FRACTURES (BOTH INTRA-OP AND POST-OP) DURING THE LAST 5 YEARS SHOWED (B)(4) COMPLAINTS. (B)(4). CONCLUSION: THE CAUSE OF THE FAILURE HAS BEEN IDENTIFIED AS RESULTING FROM IMPACTING THE UNSUPPORTED HEAD WHEN THE STEM OF THE IMPLANT HAS NOT BEEN FULLY INSERTED INTO THE MEDULLAR CANAL DUE TO AN IMPROPERLY PREPARED OBLIQUE OSTEOTOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON WAS IMPACTING THE IMPLANT WITH MINIMAL FORCE AND THE IMPLANT BROKE. A SECOND IMPLANT WAS TAKEN OUT OF THE BOX AND THE SAME THING HAPPENED. SURGEON THEN HAD TO GO TO A BIGGER SIZE BECAUSE WE HAD NO OTHER 20PS AVAILABLE WHICH ADDED ON ANOTHER 1.5 HOURS TO THE CASE. THE SURGEON IS A NEW, 1ST TIME USER OF THE PRODUCT. IT WAS REPORTED THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605539 PIP SZ. 20 PROXIMAL PIP OMX ASCENSION ORTHOPEDICS 132886T

    Patients

    Seq Age Sex Outcome Treatment
    1