BEUDAMED
    FDA Adverse Event Other Summary report: N

    PASS LP

    MDR report key: 2089796 · Received April 15, 2011

    Report

    Report Number
    1000432246-2011-00003
    Event Type
    Other
    Date Received
    April 15, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MEDICEA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K062136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO PRODUCT RETURNED FOR EVAL. REVIEW OF DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. THE SURGEON REPORTED THE PT WAS NON COMPLIANT BY LIFTING WEIGHTS. PT DID NOT FOLLOW THE SURGEON'S POST-OP RECOMMENDATIONS. CONCLUSION: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SCREW BREAKAGE IN PEDICLE MAY BE THE CONSEQUENCE OF EXCESSIVE LOADS APPLIED TO THE CONSTRUCT.

    Description of Event or Problem · 1

    SALES REP REPORTED ONE CASE OF BROKEN SCREW WITHIN THE PEDICLE DETECTED DURING POST-OP X-RAY (8 MONTHS AFTER SURGERY). PT DID NOT COMPLAIN OF ANY PAIN. PT WAS NON-COMPLIANT BY LIFTING WEIGHTS. THE DEVICE REMAINS IMPLANTED AS THE SURGEON HAS NO PLAN FOR REMOVAL BECAUSE PT HAS NO COMPLICATIONS. SURGEON WILL MONITOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASS LP POLYAXIAL PEDICLE SCREW 5.5MM X 40MM MNI MEDICEA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention