BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MGT IMPLANT - UNSPECIFIED

    MDR report key: 6145298 · Received December 5, 2016

    Report

    Report Number
    1651501-2016-00045
    Event Type
    Injury
    Date Received
    December 5, 2016
    Report Date
    October 13, 2015
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    LZJ
    PMA / PMN Number
    K102549
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 18NOV2016. THE INVESTIGATION INCLUDED: METHOD: - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: NO INFORMATION HAS BEEN PROVIDED BY COMPLAINANT THAT IDENTIFIES THE DEVICE AS OTHER THAN A GREAT TOE DEVICE. NO LOT NUMBER OR PRODUCT ID WAS GIVEN THEREFORE THE MANUFACTURING RECORD FOR THE IMPLANT COULD NOT BE DETERMINED. COMPLAINT RECORDS FOR THE SAME PRODUCT (OR SIMILAR PRODUCTS WITHIN THE PRODUCT FAMILY) FOR THE ALLEGED HAZARDOUS SITUATION/FAILURE MODE RECEIVED DURING THE LIFETIME OF THE PRODUCT, TYPICALLY 5 YEARS OR WITHIN THE STATED TIMEFRAME, WERE REVIEWED. THIS IS THE SECOND INCIDENT REPORTED OF A MOVEMENT GREAT TOE LOOSENING OR BACKING OUT AFTER IMPLEMENTATION FOR THE PAST TWO YEARS. (B)(4). CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE DOCUMENTARY INVESTIGATION AND THE LACK OF RETURNED PRODUCT OR SUPPORTIVE INFORMATION, THE ROOT CAUSE CANNOT BE DETERMINED. PER THE PRODUCT LINE RISK DOCUMENTATION, POTENTIAL ROOT CAUSE MAY BE IMPROPER BONE PREPARATION, IMPROPER SIZE SELECTION, IMPROPER PLACEMENT AND ALIGNMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE PRODUCT INITIALLY REPORTED IN MFG. REPORT 9615741-2015-00054 WAS INCORRECT. THE PRODUCT INVOLVED IS AN MGT IMPLANT. NATURE OF COMPLAINT: "LOOSENING OF IMPLANT / PAIN / METALLOSIS." ACTION TAKEN: "REMOVAL OF IMPLANT AND REVISION TO FIRST METATARSOPHALANGEAL FUSION WITH ILIAC CREST BONE GRAFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795195 MGT IMPLANT - UNSPECIFIED MOVEMENT GREAT TOE SYSTEM LZJ ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention