BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAPASS

    MDR report key: 2822386 · Received June 13, 2012

    Report

    Report Number
    1000432246-2012-00004
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    May 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    JDQ
    PMA / PMN Number
    K112736
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DEVICE HISTORY RECORD WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATION. LIGAPASS WAS IMPLANTED IN THE EXTREMITY OF CONSTRUCT. INSTRUCTION FOR USE WARNS THAT ¿LIGAPASS SYSTEM MUST NOT BE IMPLANTED IN THE EXTREMITIES OF THE CONSTRUCT.¿ CONCLUSION: LIGAPASS MAY HAVE BEEN OVERLOADED BECAUSE OF THE POSITION IN EXTREMITY OF CONSTRUCT, WHICH IS WARNED AGAINST.

    Description of Event or Problem · 1

    SURGEON WAS DOING A DECOMPRESSION AT T3 AND NOTICED THAT THE LIGAPASS BANDS WERE BROKEN. THE PT HAD THIS LIGAPASS IMPLANTED JUST A FEW WEEKS BEFORE. THE SURGEON HAD PREVIOUSLY IMPLANTED PASS LP HARDWARE IN THE PT IN (B)(6), THEN WENT BACK A FEW WEEKS LATER AND EXTENDED HER UP TO T3 WITH LIGAPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAPASS CERCLAGE JDQ MEDICREA TECHNOLOGIES 11K0443

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention