BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 6306040 · Received February 6, 2017

    Report

    Report Number
    1000432246-2011-00015
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    February 10, 2011
    Report Date
    January 27, 2017
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K062136
    Product Problem
    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. THE SURGEON REPORTED THE PATIENT WAS NONCOMPLIANT BY LIFTING WEIGHTS. PATIENT DID NOT FOLLOW THE SURGEON'S POST-OP RECOMMENDATIONS. DEVICE NOT RETURNED. CONCLUSION IT IS SUSPECTED THAT THE PRODUCT MET SPECIFICATION. SCREW BREAKAGE IN PEDICLE MAY BE THE CONSEQUENCE OF EXCESSIVE LOADS APPLIED TO THE CONSTRUCT. NOTE: THIS MDR WAS SUBMITTED AS 1000432246-2011-00003 ON 04/15/2011, BUT IT NOT SHOW UP IN MAUDE. WE CONTACTED FDA SEVERAL TIMES WITH NO RESOLUTION. FINALLY IN JANUARY 2011 WE WERE DIRECTED TO RESUBMIT IT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTED ONE CASE OF BROKEN SCREW WITHIN THE PEDICLE DETECTED DURING 8 MONTH POST-OP X-RAY. PATIENT DID NOT COMPLAIN OF ANY PAIN. PATIENT WAS NONCOMPLIANT BY LIFTING WEIGHTS. THE DEVICE REMAINS IMPLANTED AS THE SURGEON HAS NO PLAN FOR REMOVAL BECAUSE PATIENT HAS NO COMPLICATIONS. SURGEON WILL MONITOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86688 PASS LP POLYAXIAL SCREW MNI MEDICREA INTERNATIONAL Ø505 X 40 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention