BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 6306028 · Received February 6, 2017

    Report

    Report Number
    1000432246-2011-00014
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    February 14, 2011
    Report Date
    January 27, 2017
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K080099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PRODUCT NOT RETURNED FOR EVALUATION. REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED; ADDITIONAL INFORMATION HAS BEEN REQUESTED TO INVESTIGATE THE ADVERSE EVENT. CONCLUSION: NO CONCLUSION COULD BE PROVIDED AS INSUFFICIENT INFORMATION HAS BEEN PROVIDED. NOTE: THIS MDR WAS SUBMITTED AS 1000432246-2015-00002 IN 04/15/2011. IT IS NOT SHOW UP IN MAUDE. WE CONTACTED FDA SEVERAL TIMES WITH NOT RESOLUTION. FINALLY IN JANUARY 2017 RECEIVED DIRECTION TO RESUBMIT MDR. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IN FEBRUARY 2011 SALES REPRESENTATIVE REPORTED ONE CASE OF BROKEN SCREWS (2), DETECTED DURING REVISION FOR BACK PAIN. SCREW FAILURES WERE NOT DETECTED BEFORE RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86376 PASS LP POLYAXIAL PEDICLE SCREW MNI MEDICREA INTERNATIONAL Ø7.5 X 45 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention