BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE

    MDR report key: 4110199 · Received September 11, 2014

    Report

    Report Number
    3005977257-2014-00006
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RETURNED. NO ANALYSIS CAN BE DONE AT THE ITEM OF THIS REPORT. IT IS EXPECTED THAT THE PATIENT WILL BE REVISED PER PHYSICIANS DISCRETION. THE REPORT WILL BE RE-SUBMITTED IF THE PART IN QUESTION BECOMES AVAILABLE. THE COMPLAINT FILE WILL BE CLOSED IF NO PARTS ARE RETURNED WITHIN 90 DAYS. (B)(6).

    Description of Event or Problem · 1

    DURING PATIENT FOLLOW UP, SIX MONTHS FOLLOWING SURGERY, IT WAS DISCOVERED THAT A PEDICLE SCREW WAS BROKEN. HOWEVER, THE EVENT WAS NOT REPORTED UNTIL (B)(6) 2014. DUE TO THE FACT THAT THE EVENT WAS DISCOVERED DURING A FOLLOW UP VISIT, FURTHER INFORMATION REGARDING THE TIMING FO THE EVENT COULD NOT BE DETERMINED. IT IS EXPECTED THAT THE PATIENT WILL BE REVISED BUT REVISION SURGERY HAS NOT YET BEEN SCHEDULED. NO ADDITIONAL INFORMATION REGARDING THE PRODUCT OR THE CIRCUMSTANCES SURROUNDING THE BREAK WERE AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562316 PEDFUSE PEDICLE SCREW MNI SPINEFRONTIER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALLOGRAFT: SN (B)(4)