BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3223306 · Received July 12, 2013

    Report

    Report Number
    1000432246-2013-00007
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON USED A PASS LP SYSTEM ON 9 LEVELS, T4-L1. THE BROKEN PEDICLE WAS ON THE RIGHT SIDE AT T5 LEVEL. THE SURGEON USED A LIGAPASS SYSTEM AT T5 LEVEL. THE 510K - K123138. (B)(4) - NUT; (B)(4) - POLYAXIAL PEDICLE SCREW Ø4.5 X 40MML; (B)(4) - POLYAXIAL PEDICLE SCREW Ø5.5 X 35MML; (B)(4) - POLYAXIAL PEDICLE SCREW Ø5.5 X 40MML; (B)(4) - STANDARD CONNECTOR FOT Ø6MM ROD; (B)(4) - TI ROD Ø6 X 280MML; (B)(4) - TRANSVERSE COUNTER HOOK, 11MM - 3MM; (B)(4) - SHORT THORACIC COUNTER HOOK; (B)(4) - CROSSLINK FOR Ø6 ROD, 22MM - 34MML. THE 510K - K082577. (B)(4) - DEROTATION CONNECTOR. THE 510K - K112736. (B)(4) - LIGAPASS CONNECTOR. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE SURGEON'S HAND SLIPPED OFF THE PROBE HANDLE WHILE PUSHING ON THE INSTRUMENT INTO THE PEDICLE. CONSEQUENTLY, THE WALL OF THE PEDICLE WAS BROKEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323445 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization