BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 2338354 · Received September 16, 2011

    Report

    Report Number
    1000432246-2011-00007
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 14, 2011
    Manufacturer
    MEDICREA INTL.
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: MEDIAL BREECH WAS REVEALED BY CT-SCAN AND CONFIRMED DURING REVISION. LEG PAIN SHOULD BE CONSEQUENCE OF MEDIAL BREECH. CONCLUSION: THIS EVENT IS DIRECTLY RELATED TO SURGERY AND NOT TO THE DEVICE. IMPLANTS USED IN SURGERY INCLUDED: 510K K080099, (B)(4): POLYAXIAL SCREW DIAMETER 5.5, LENGTH 35MM; (B)(4): POLYAXIAL SCREW DIAMETER 5.5, LENGTH 40MM; (B)(4): POLYAXIAL SCREW DIAMETER 5.5, LENGTH 45MM; (B)(4): ROD DIAMETER 6MM, LENGTH 160MM; (B)(4): CROSSLINK FOR ROD DIAMETER 6MM; (B)(4): NUT; 510K K082577, (B)(4): DEROTATION CONNECTOR.

    Description of Event or Problem · 1

    PT HAS A CORRECTED SPINAL SURGERY, POST-OP IT WAS NOTED THAT SHE WAS DEVELOPING SOME LEG PAIN. CT SCAN REVEALED MEDIAL BREECH OF THE L3 SCREW AND POSSIBLE L2 SCREW. REVISION SURGERY HAS BEEN PERFORMED TO REPLACE SCREWS WITH SUBLAMINAR FIXATION. LEG PAIN HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASS LP PEDICLE SCREW MNI MEDICREA INTL. 07A0044

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention