BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 2696116 · Received February 2, 2012

    Report

    Report Number
    1000432246-2011-00013
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    August 5, 2011
    Report Date
    January 31, 2012
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: EXPLANTS SHOW NO PARTICULAR DAMAGE. THREE POSSIBLE CAUSES ARE IDENTIFIED TO EXPLAIN THE INCIDENT: LACK OF INITIAL TIGHTENING RELATED TO DIFFICULTY IN CONFIGURING THE IMPLANTS (VERY DYSMORPHIC SPINAL COLUMN); A PARTIAL RELEASE OF THE ASSEMBLY DUE TO ONE TIME EFFORT APPLIED BY THE PARTICULAR DEFORMED SPINAL COLUMN (VERY DYSMORPHIC SPINAL COLUMN); THE COMBINATION OF THE PHENOMENA ABOVE. CONCLUSION: THIS EVENT SHOULD BE DIRECTLY RELATED TO CHARACTERISTICS OF VERY DYSMORPHIC PATIENT SPINAL COLUMN.

    Description of Event or Problem · 1

    IN (B)(6) 2011, PATIENT WITH SCOLIOSIS HAS BEEN OPERATED ON WITH PASS LP SYSTEM. SHE COMPLAINED OF POST-OP PAIN. AT ONE MONTH POST-OP, SURGEON DETECTED SLIPPAGE OF THE TWO CLAMPS HOOKS TRANSVERSE PEDICULAR-TRANSVERSE APICAL ASSEMBLY AND SLIGHT ROTATION OF THE UPPER TWO RODS. REVISION WAS PERFORMED (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASS LP PEDICLE SCREW MNI MEDICREA INTERNATIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention 510K K082069| LARGE POLYAXIAL PEDICULAR HOOK FOR CLAW: (B)(4)| LONG TRANSVERSE COUNTER HOOK: (B)(4)| STANDARD CONNECTING CLAMP FOR 6MM ROD: (B)(4)