BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTA NAIL 10MM X 150MM

    MDR report key: 1005420 · Received February 29, 2008

    Report

    Report Number
    9612007-2008-00006
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION. 311 ENTERPRISE DRIVE. PLAINSBORO, NJ 08536. ATTN: CORPORATE COMPLAINT COORDINATOR.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS, THAT WHEN THE PHYSICIAN WAS PREPARING FOR THE PROCEDURE, HE ATTEMPTED TO ASSEMBLE THE 10 MM PANTA NAIL TO THE COMPRESSION DEVICE; BUT THE NAIL FIXATION AXIS WHICH HOLDS THE NAIL INTO THE COMPRESSION DEVICE WAS NOT ENGAGING THE DISTAL THREADS OF THE NAIL. A SECOND NAIL OF THE SAME SIZE AND FROM THE SAME LOT WAS AVAILABLE THAT ALSO DID NOT ENGAGE. NO PATIENT CONTACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANTA NAIL 10MM X 150MM PANTA NAIL JDS INTEGRA NEUROSCIENCES IMPLANTS S.A. E7XX

    Patients

    Seq Age Sex Outcome Treatment
    1