BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 2338337 · Received November 11, 2011

    Report

    Report Number
    1000432246-2011-00011
    Event Type
    Injury
    Date Received
    November 11, 2011
    Date of Event
    July 8, 2011
    Report Date
    November 1, 2011
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: REVIEW OF DEVICE HISTORY WAS NOT POSSIBLE AS LOT NUMBER WAS NOT PROVIDED. X-RAY DOES NOT REVEAL ANY FAILURE OF DEVICE. CONCLUSION: INVESTIGATION COULD NOT LEAD TO DEFINE THE PRECISE ROOT CAUSE OF THIS ADVERSE EVENT. IMPLANTS USED IN SURGERY INCLUDED: 510K K080099. (B)(4): POLYAXIAL SCREW DIAMETER 5.5, LENGTH 30MM, (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): POLYAXIAL SCREW DIAMETER 6.5, LENGTH 35MM, (B)(4): POLYAXIAL SCREW DIAMETER 6.5, LENGTH 40MM, (B)(4): NUT. 510K K100297. (B)(4): COCR ROD DIAMETER 5.5MM, LENGTH 500MM. 510K K082577. (B)(4): DEROTATION CONNECTOR. (B)(4): STANDARD CONNECTOR FOR DIAM 5.5MM ROD.

    Description of Event or Problem · 1

    PATIENT HAD SURGERY (B)(6) 2011 TO TREAT IDIOPATHIC SCOLIOSIS T4-L2. PATIENT COMPLAINED OF SEVERE BACK PAIN 22 DAYS POST-OP. PATIENT WAS ADMITTED FOR PAIN CONTROL. AFTER 48 HOUR MEDICATION TREATMENT, PAIN DECREASED SIGNIFICANTLY AND THE PATIENT WAS DISCHARGED. PATIENT WAS PRESCRIBED PAIN MEDICATION TO TAKE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASS LP PEDICLE SCREW MNI MEDICREA INTERNATIONAL NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization