BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3223192 · Received July 12, 2013

    Report

    Report Number
    1000432246-2013-00010
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 24, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAYS SHOW A PASS LP SYSSTEM ON 8 LEVELS, T10-S1, USING POLYAXIAL PEDICLE SCREWS, STANDARD CONNECTORS, OFFSET CONNECTORS, SHORT ILIAC CONNECTOR ANGLED LEFT AND CROSSLINK. THE X-RAYS PROVIDED DO NOT SHOW ANY FAILURE OF THE HARDWARD. THE ADVERSE EVENT OF VERTIGO IS NOT REPORTED AS A COMPLICATION IN THE PUBLICATIONS AND IN MEDICREA ADVERSE EVENTS DATA BASE. PMA 510K - K123138. B02013005 - NUT. B02215545 - POLYAXIAL PEDICLE SCREW, Ø5.5 X 45MML. B02215550 - POLYAXIAL PEDICLE SCREW, Ø5.5 X 50MML. B02216540 - POLYAXIAL PEDICLE SCREW, Ø6.5 X 40MML. B02216545 - POLYAXIAL PEDICLE SCREW, Ø6.5 X 45MML. B02216550 - POLYAXIAL PEDICLE SCREW, Ø6.5 X 50MML. B02217590 - POLYAXIAL ILIAC SCREW, Ø7.5 X 90MML. B02236001 - STANDARD CONNECTOR FOR Ø6MM ROD. B02235040 - OFFSET CONNECTOR FOR Ø6MM ROD. B02266034 - CROSSLINK FOR Ø6MM ROD, 22MM TO 34MM LENGTH. B02236053 - SHORT ILIAC CONNECTOR ANGLE LEFT. B02235055 - SHORT ILIAC CONNECTOR. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO THE OPERATING ROOM ON (B)(6) 2013, FOR VERTIGO-LIKE SYMPTOMS, WHICH WERE LATER DIAGNOSED AS INNER-EAR CRYSTALS. PATIENT WAS HELD FOR 48 HOURS FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321444 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization