BEUDAMED
    FDA Adverse Event Other Summary report: N

    APASS LP

    MDR report key: 2163680 · Received June 15, 2011

    Report

    Report Number
    1000432246-2011-00004
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    May 15, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K082577
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE SURGEON PRESCRIBED EXTENDED HOSPITALIZATION SINCE THE PT'S PAIN NEEDED TO BE CONTROLLED BETTER. DURING THIS TIME, PT WAS OBSERVED WHILE RECEIVING PAIN MANAGEMENT THERAPY, AND PHYSICAL THERAPY CONTINUED UNTIL PAIN TOLERANCE IMPROVED. CONCLUSION: THIS EVENT IS DIRECTLY RELATED TO SURGERY AND NOT TO THE DEVICE. IMPLANTS USED IN SURGERY INCLUDED: B02266034: CROSSLINK FOR 6 MM ROD, LENGTH 22 TO 34 MM. B99100210: 510K# K082577. B02236001: STANDARD CONNECTING CLAMP FOR 6 MM ROD. B0213005: BREAK AWAY NUT. B02241106: LARGE, POLYAXIAL PEDICULAR HOOK FOR CLAW. B02242308: SHORT, TRANSVERSE COUNTERHOOK.

    Description of Event or Problem · 1

    IN (B)(6) 2011, A SURGEON REPORTS ONE CASE OF EXTENDED HOSPITALIZATION. PT HAD SPINAL FUSION SURGERY ON (B)(6) 2011. PT WAS FEELING FINE AND WAS SCHEDULED TO BE DISCHARGED ON (B)(6) 2011. PT COMPLAINED THAT PAIN WAS NOT CONTROLLED AND WAS RELEASED FROM THE HOSPITAL UNTIL PAIN WAS MANAGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization