BEUDAMED
    FDA Adverse Event Summary report: N

    LIGAPASS

    MDR report key: 2708983 · Received April 18, 2012

    Report

    Report Number
    1000432246-2012-00002
    Date Received
    April 18, 2012
    Date of Event
    March 22, 2012
    Report Date
    April 15, 2012
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    JDQ
    PMA / PMN Number
    K112736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DURING SURGERY BAND WAS OVER TIGHTENED WITHIN INSTRUMENT. USUALLY, AS SURGICAL TECHNIQUE DESCRIBES, THE TOTAL REDUCTION IS COMPLETED WHEN THE BAND, OF CONCAVE SIDE, IS FULLY TIGHTENED. AFTER THIS STEP WAS COMPLETED, SURGEON CONTINUED TO TIGHTEN THE BAND AND OVER LOADED BAND. CONCLUSION: BAND RUPTURE WAS THE RESULT OF OVER LOADING DURING TIGHTENING STEP. SURGICAL TECHNIQUE WAS NOT PROPERLY FOLLOWED. IMPLANTS USED IN SURGERY AND IMPLICATED IN INCIDENT: B08106010: BAND AND CONNECTOR; A08100010: TENSION PULLEY.

    Description of Event or Problem · 1

    IN (B)(6) 2012, (B)(4) PROJECT MANAGER REPORTED ONE CASE OF BROKEN AND DETECTED DURING SURGERY. THIS INCIDENT OCCURRED DURING FINAL STEP OF TIGHTENING WITH TENSION PULLEY. CONSTRUCT WAS ALREADY SECURED, SURGEON CONSIDERED THAT THIS INCIDENT WILL NOT LEAD TO PT ISSUE, SO THE BROKEN BAND WAS LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAPASS CERCLAGE, PRODUCT CODE: JDQ JDQ MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other