BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MGT MOVEMENT PROX. PHAL. TOTAL SZ 20

    MDR report key: 3810009 · Received May 1, 2014

    Report

    Report Number
    1651501-2014-00022
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    LZJ
    PMA / PMN Number
    K102549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS CONCERNING THE SAME PATIENT. (SEE MFG REPORT NUMBER 1651501-2014-00021). THIS REPORT CONCERNS THE MOVEMENT GREAT TOES SYSTEM (MGT) MOVEMENT PROXIMAL PHALANX. TOTAL SIZE 20 (PRODUCT ID MGT-890-20PPT). IT WAS REPORTED: 'SURGERY WAS AN MGT TOTAL TOE. SURGERY WENT FINE BUT THE PATIENT SOON BEGAN TO HAVE PAIN. THE SURGEON WENT BACK IN TO REPLACE THE IMPLANT AND FOUND THAT THE COBALT CHROME HAD PEELED OFF THE HEAD OF THE IMPLANT.' ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR ON (B)(6)-2014. THE DATE OF THE INITIAL IMPLANT SURGERY WAS (B)(6)-2013. THE IMPLANT WAS IMPLANTED IN THE LEFT FOOT OF THE PATIENT. THE PATIENT HAD DISCOMFORT SOON AFTER THE SURGERY WHICH PROGRESSED UNTIL THE IMPLANT WAS REMOVED (AND TOE WAS LATER FUSED) ON (B)(6)-2014. THE PATIENT CONDITION TO DATE WAS REPORTED AS 'IMPROVED'. THE IMPLANT WAS REPORTED GIVEN TO THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261893 MGT MOVEMENT PROX. PHAL. TOTAL SZ 20 MOVEMENT GREAT TOE LZJ ASCENSION ORTHOPEDICS 10-1204

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention