BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3223311 · Received July 12, 2013

    Report

    Report Number
    1000432246-2013-00009
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    March 7, 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

    METHOD OF EVALUATION: THERE WAS NO FAILURE OF THE HARDWARE, THEREFORE EVALUATION OF HARDWARE IS NOT APPROPRIATE. X-RAYS SHOW A PASS LP SYSTEM ON 8 LEVELS, T10-S1 USING POLYAXIAL PEDICLE SCREW, STANDARD CONNECTORS, OFFSET CONNECTORS, SHORT ILIAC CONECTOR ANGLED LEFT AND CROSSLINK. THE X-RAYS PROVIDED DO NOT SHOW ANY FAILURE OF THE HARDWARE. ACCORDING TO THE NATURE OF THE SURGERY (OPERATION LENGTH, INCISION LENGTH, INVASIVE NATURE OF THE SURGERY), POST-OPERATIVE PAIN IS NOT AN UNKNOWN AND UNEXPECTED ADVERSE EVENT FOLLOWING POSTERIOR SPINAL FUSION AND IS LISTED IN IFU AS A POSSIBLE UNDESIREABLE EFFECT. 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 2 WEEKS POST-OP FOR PAIN CONTROL AS WELL AS MOBILITY. THE PHYSICIAN ORDERED THAT PATIENT TO BE TREATED BY PHYSICAL THERAPY, WHICH IS TO GO THROUGH THE EXERCISES TO EASE THE PAIN BY BUILDING MUSCLES. THE PATIENT WAS DISCHARGED WHEN SHE REGAINED PRE-OPERATIVE STRENGTH AND MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323928 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization