BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3062530 · Received April 17, 2013

    Report

    Report Number
    1000432246-2013-00002
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    December 3, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: MANUFACTURING RECORD 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 1 LEVEL, L2-S1, USING A PLATE SYSTEM. THE ORIENTATION OF THE ROD DOESN'T APPEAR CLEARLY ON THE X-RAY AND THROUGH THIS DATA IT IS DIFFICULT TO CONFIRM THE CORRECT POSITIONING OF THE IMPLANT. THERE WAS NO INFORMATION ON THE GRAFTING TECHNIQUE USED. THERE WAS NO VISIBLE SIGN OF FUSION. THE ABSENCE OF FUSION, 8 MONTHS LATER, CAUSES A HIGH RISK OF FAILURE OF THE OSTEOSYNTHESIS SYSTEM, WHICH IS INSERTED TO SUPPORT THE SPINAL COLUMN DURING THE CONSOLIDATION PHASE ESTIMATED AT 6-9 MONTHS. NO INFORMATION WAS AVAILABLE ABOUT THE OBSERVATIONS MADE DURING REVISION REGARDING THE PRESENCE OF BONE FUSION. B02270010 - LOT 11E0026: ROD PLATE. B02216540 - LOT 11D0279: POLYAXIAL PEDICLE SCREW.

    Description of Event or Problem · 1

    THE PT WAS OPERATED ON (B)(6) 2012 WITH PASS LP SYSTEM ON 1 LEVEL, L5-S1. HE HAS BEEN REVISED 8 MONTHS LATER DUE TO POST-OP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165533 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA TECHNOLOGIES 11E0026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention