BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 4781494 · Received May 19, 2015

    Report

    Report Number
    1000432246-2015-00001
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    March 24, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K123138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS: B02216550 - POLYAXIAL PEDICLE SCREW, Ø6.5 X 50MM L. B02216555 - POLYAXIAL PEDICLE SCREW, Ø6.5 X 55MM L. B02216560 - POLYAXIAL PEDICLE SCREW, Ø6.5 X 60MM L. B02217590 - POLYAXIAL ILIAC SCREW, Ø7.5 X 90MM L. B02176005 - TI PRE-BENT ROD, Ø6 X 50MM L. B02246001 - STANDARD CONNECTOR FOR Ø6MM ROD. B02286010 - ILIAC LINK FOR Ø6MM ROD. B0213005 - NUT. X-RAYS SHOW A PASS LP SYSTEM ON 6 LEVELS L1-S1 USING POLYAXIAL PEDICLE SCREWS, STANDARD CONNECTORS, ILIAC SCREW, ILIAC LINKS FOR Ø6MM ROD AND PRE-BENT Ø6MM RODS. THE X-RAYS PROVIDED DO NOT SHOW ANY FAILURE OF THE HARDWARE. ACCORDING TO THE NATURE OF THE SURGERY, FRACTURE IS NOT AN UNKNOWN AND UNEXPECTED ADVERSE EVENT FOLLOWING POSTERIOR SPINAL FUSION AND IS LISTED IN IFU AS A POSSIBLE UNDESIREABLE EFFECT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    POSTOPERATIVE EVENT RESULTING IN FRACTURE OF BOTH PEDICLES, WITH FRACTURE EXTENDING VERTICALLY THROUGH THE ANTERIOR MID PORTION OF THE L1 VERTEBRAL BODY. THE FRACTURE WAS DETECTED DURING A FOLLOW-UP 12 MONTHS AFTER THE SURGERY. THE SURGEON SUGGESTED TO THE PATIENT THAT THE FUSION BE REVISED WITH T3-L1 POSTERIOR FUSION AND L1 OSTEOTOMY. THIS DOES NOT NEED TO BE DONE URGENTLY, AS THE FRACTURES APPEAR TO BE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324777 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention