BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3062528 · Received April 17, 2013

    Report

    Report Number
    1000432246-2013-00003
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    December 5, 2012
    Report Date
    February 12, 2013
    Manufacturer
    MEDICREA
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: MFG 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 SYS ON 4 LEVELS, L2-S1, USING ANGULATED, REALIGNMENT AND STANDARD CONNECTORS. THE ROD IS VERY STRAIGHT FOR A CORRECTION OF THE LUMBAR SPINE. THE DISTAL PART OF THE ROD SEEMS TO BE IN CONTACT WITH THE SACRUM WHICH CAN CREATE AN OVER-LOADING ON THE LAST ANCHORING POINT. THERE WAS NO INFO ON THE GRAFTING TECHNIQUE USED. THERE WAS NO VISIBLE SIGN OF FUSION. THE ABSENCE OF FUSION, SIX MONTHS POST-OP, CAUSES A HIGH RISK OF FAILURE OF THE OSTEOSYNTHESIS SYS, WHICH IS INSERTED OT SUPPORT THE SPINAL COLUMN DURING THE CONSOLIDATION PHASE ESTIMATED TO BE 6-9 MONTHS. NO INFO IS AVAILABLE ABOUT THE OBSERVATIONS MADE DURING REVISION REGARDING THE PRESENCE OF BONE FUSION. A 510K - K080099: B02126014 - LOT 11G0084: ROD, B02236001 - LOT 11I0220: STANDARD CONNECTOR, B02236010 - LOT 11C0247: REALIGNMENT CONNECTOR, B02266062 - LOT 11K0042: CROSSLINK, B02216545 - LOT 10L0314: POLYAXIAL PEDICLE SCREW, B02216545 - LOT 11L0043 AND 12A0234: POLYAXIAL PEDICLE SCREW AND B02217545 - LOT 11H0081: POLYAXIAL PEDICLE SCREW. A 510K - K083308: B02236030 - LOT 10G0274: ANGULATED CONNECTOR.

    Description of Event or Problem · 1

    THE PT WAS OPERATED ON (B)(6) 2012 WITH PASS LP SYS ON 4 LEVELS, L1-L5. HE HAS BEEN REVISED SIX MONTHS LATER DUE TO POST-OP PAIN. DURING REVISION THE SURGEON NOTICED THAT NUTS SEEMED TO BE EASILY UNSCREWED, WHICH COULD EXPLAIN THE MOVEMENTS FOR THE ROD AND CAUSED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166275 PASS LP POSTERIOR PEDICLE SCREW SYSTEM, PRODUCT CODE: MNI MNI MEDICREA 11G0084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention