BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3062529 · Received April 17, 2013

    Report

    Report Number
    1000432246-2013-00001
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 12, 2013
    Manufacturer
    MEDICREA TECHNOLOGIES
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: MANUFACTURING RECORDS OF RETURNED IMPLANTS WERE REVIEWED. ANY COMPLIANCE WITH THE REQUIRED SPECIFICATIONS HAS BEEN DETECTED. IMPLANTS SHOW NO PARTICULAR DAMAGE. X-RAY SHOWS A PASS LP SYSTEM ON 4 LEVELS, L2-S1, USING ANGULATED, REALIGNMENT AND STANDARD CONNECTORS. THE LOWER EXTREMITY OF THE ROD DOESN'T EXCEED THE CONNECTOR, SO SUCH A CONFIGURATION COULD ENGENDER A LOOSENING OF THE IMPLANTS. THERE WAS NO INFORMATION ON THE GRAFTING TECHNIQUE USED. THERE WAS NO VISIBLE SIGN OF FUSION. THE ABSENCE OF FUSION, 18 MONTHS POST-OP, CAUSES A HIGH RISK OF FAILURE OF THE OSTEOSYNTHESIS SYSTEM, WHICH IS INSERTED TO SUPPORT THE SPINAL COLUMN DURING THE CONSOLIDATION PHASE, ESTIMATED TO BE 6 - 9 MONTHS. NO INFORMATION IS AVAILABLE ABOUT THE OBSERVATIONS MADE DURING REVISION REGARDING THE PRESENCE OF BONE FUSION. THE 510K - K080099: B02176010 - LOT 10F0091 PRE-BENT ROD, B02236001 - LOT 10G0321 STANDARD CONNECTOR, B02236010 - LOT 10I0453 AND 10I0454 REALIGNMENT CONNECTOR, B02266048 - LOT 11A0366 CROSSLINK, B02216545 - LOT 10L0314 POLYAXIAL PEDICLE SCREW, B02216540 - LOT 11A0006 AND 11A0049 POLYAXIAL PEDICLE SCREW. THE 510K - K083308: B02236030 - LOT 10J0393 ANGULATED CONNECTOR.

    Description of Event or Problem · 1

    THE PT WAS OPERATED ON (B)(6) 2011, WITH PASS LP SYSTEM ON 4 LEVELS LS-S1. HE HAS BEEN REVISED 18 MONTHS LATER DUE TO POST-OP PAIN. DURING REVISION, THE SURGEON NOTICED THAT THE NUTS SEEMED TO BE EASILY UNSCREWED, WHICH COULD EXPLAIN THE MOVEMENTS OF THE ROD AND CAUSED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164376 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA TECHNOLOGIES 10F0091

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention