BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP - LIGAPASS

    MDR report key: 3369451 · Received April 26, 2013

    Report

    Report Number
    1000432246-2013-00005
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    JDQ
    PMA / PMN Number
    K112736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CHECKING THE COMPLIANCE OF THE RETURNED DEVICE WITH REQUIREMENTS IS NOT PRACTICABLE. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THE RESULTS OF TESTS PERFORMED ON THE DEVICE DURING ITS MFG COMPLY WITH REQUIREMENTS. LIGAPASS IMPLANTED ON SPINE GROWING CONSTRUCT. INSTRUCTIONS FOR USE WARNS THAT "LIGAPASS IS A TEMPORARY IMPLANT FOR USE IN ORTHOPEDICS SURGERY ON SKELETALLY MATURE PTS." CONCLUSION: IMPLANT WAS USED OFF LABEL. IMPLANT USED IN SURGERY INCLUDED: 510K - K112736, CAT # B08106010, LOT # 12B0155, EXPIRATION DATE 01/2017, CAT # B08106010, LOT # 12B0460, EXPIRATION DATE 02/2017.

    Description of Event or Problem · 1

    A LIGAPASS CLAMP WAS USED AS A RIB ANCHOR ON A ROD CONSTRUCT IMPLANTED IN A SKELETALLY NON-MATURE PERSON. IMPLANT FAILED AT 6 WEEKS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183365 PASS LP - LIGAPASS LIGAPASS JDQ MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention