BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAPASS

    MDR report key: 3129717 · Received May 24, 2013

    Report

    Report Number
    1000432246-2013-00006
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    JDQ
    PMA / PMN Number
    K112736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHECKING THE COMPLIANCE OF THE RETURNED DEVICE WITH THE SPECIFICATIONS IS NOT PRACTICAL. 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 THE MANUFACTURING COMPLY WITH THE SPECIFICATIONS. LIGAPASS WAS IMPLANTED ON A SPINE THAT WAS STILL GROWING. INSTRUCTIONS FOR USE WARN THAT "LIGAPASS IS A TEMPORARY IMPLANT FOR USE IN ORTHOPEDIC SURGERY ON SKELETALLY MATURE PATIENTS." CONCLUSION: IMPLANT WAS USED OFF LABEL. IMPLANTS USED IN SURGERY INCLUDED: B0106010, LOT 12B0155, EXPIRATION DATE 01-2017. B0106010, LOT 12E0134, EXPIRATION DATE 05-2017.

    Description of Event or Problem · 1

    THE PATIENT FELT A "POP" IN HER BACK AND UPON X-RAY EXAM, THE SURGEON NOTICED THE ROD PULLING AWAY. THE BAND BROKE. A LIGAPASS CLAMP HAD BEEN USED AS A RIB ANCHOR ON A ROD CONSTRUCT IMPLANTED IN A SKELETALLY IMMATURE PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231700 LIGAPASS CERCLAGE JDQ MEDICREA INTERNATIONAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention