BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 3223230 · Received July 12, 2013

    Report

    Report Number
    1000432246-2013-00008
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROXIMAL JUNCTIONAL KYPHOSIS (PJK) FOLLOWING POSTERIOR INSTRUMENTED SPINAL FUSION IS A KNOWN COMPLICATION THAT HAS BEEN OBSERVED AND PUBLISHED IN ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS). PJK IS MORE LIKELY TO HAPPEN FOR LARGER PRE-OPERATIVE THORACIC KYPHOSIS ANGLE (T5-T12 >40°), GREATER IMMEDIATE POST-OPERATIVE THORACIC KYPHOSIS ANGLE DECREASE (DECREASE >5°), THORACOPLASTY AND FOR MEN. THERE IS NO RISK FACTOR RELATED TO INSTRUMENTATION TYPE. THE OCCURRENCE VARIES BETWEEN 26% AN 46% AT 2 YEARS OF FOLLOW-UP. THE 510K - K123138. B02241106 - LARGE POLYAXIAL PEDICULAR HOOK FOR CLAW; B02214535 - POLYAXIAL PEDICLE SCREW Ø4.5 X 35MML; B02215535 - POLYAXIAL PEDICLE SCREW Ø5.5 X 35MML; B02215540 - POLYAXIAL PEDICLE SCREW Ø5.5 X 40MML; B02215035 - POLYAXIAL PEDICLE SCREW Ø5.0 X 35MML; B02215040 - POLYAXIAL PEDICLE SCREW Ø5.0 X 40MML; B02216545 - POLYAXIAL PEDICLE SCREW Ø6.5 X 40MML; B02236001 - STANDARD CONNECTOR FOT Ø6MM ROD; B02126028 - COCR ROD Ø6 X 500MML; B02245311 - TRANSVERSE COUNTER HOOK, 11MM - 3MM; B02242407 - SHORT THORACIC COUNTER HOOK; B02266034 - CROSSLINK FOR Ø6 ROD, 22MM - 34MML. THE 510K - K082577; B99100210 - DEROTATION CONNECTOR. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT INITIAL SF ON (B)(6) 2011; LEVELS T5-L3 WERE FUSED WITHOUT INCIDENCE. AT 6 MONTH AND 12 MONTH VISITS PATIENT NOTED BACK PAIN AND PHYSICAL THERAPY WAS PRESCRIBED. PER SOURCE DOCUMENT, UPON PHYSICAL EXAM, PATIENT DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS WITH PROMINENCE OF SPINAL HARDWARE. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 TO EXTEND CONSTRUCT TO T3 AND REDUCE HARDWARE PROMINENCE. PER SOURCE DOCUMENT, PATIENT TOLERATED SURGERY WELL AND WAS DISCHARGED ON (B)(6) 2013. PATIENT IS SCHEDULED FOR 1ST POST-OP VISIT WITH PI ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321577 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention