BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEON SHAPE MEMORY IMPLANT (AKA STIMULINK)

    MDR report key: 1036201 · Received April 29, 2008

    Report

    Report Number
    3005509435-2008-00002
    Event Type
    Injury
    Date Received
    April 29, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 28, 2008
    Manufacturer
    INTELIFUSE, INC.
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES RECEIVED AT INTELIFUSE, INC 04/23/2008 AND PHOTOGRAPHED. DEVICES FORWARDED TO (B) (4) FOR FURTHER REVIEW ON 04/28/2008.

    Description of Event or Problem · 1

    A CLOSING WEDGE OSTEOTOMY WAS PERFORMED ON (B) (6) 2008. TWO IMPLANTS (10X10MM AND 13X10MM) WERE IMPLANTED INTO THE 4TH AND 3RD METATARSALS, RESPECTIVELY. THE SURGEON NOTED THAT INTRAOPERATIVE XRAYS SHOWED THE 10X10 IMPLANT LEGS TO BE FURTHER APART THAN THOSE OF THE 13X10 IMPLANT AND THE 10X10 IMPLANT WAS MANIPULATED MANUALLY. THE 10X10 IMPLANT APPEARED TO BE SECURE AND THE SURGERY WAS ENDED WITHOUT FURTHER INCIDENT. THE PT RETURNED TO THE SURGEON'S OFFICE ON (B) (6) 2008, AND ADDITIONAL XRAYS WERE PERFORMED. PER THE SURGEON, THIS WAS A ROUTINE FOLLOW UP AND ROUTINE XRAY. UPON REVIEW OF THE XRAYS THE SURGEON NOTIFIED THE SALES REP THAT THE 10X10 IMPLANT "POPPED DORSALLY" OUT WHILE THE 13X10 IMPLANT APPEARED INTACT AND THAT A REVISION SURGERY WAS PLANNED FOR (B) (6) 2008. THE SURGEON STATED THAT THE PT COULD NOT REMEMBER IF SHE HAD OR HAD NOT PUT ANY WEIGHT ON THE FOOT. DURING THE REVISION SURGERY ON (B) (6) 2008, THE 10X10 IMPLANT WAS REMOVED AND REPLACED WITH ALTERNATE FIXATION DEVICE. THE SURGEON SIMULATED WEIGHT BEARING PRIOR TO CLOSING THE SURGICAL SITE AND NOTICED THAT THE SECOND ORIGINAL IMPLANT (13X10) BECAME LOOSE AND WAS ALSO REPLACED. SEE ALSO 3005509435-2008-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEON SHAPE MEMORY IMPLANT (AKA STIMULINK) INTELIFUSE SHAPE MEMORY IMPLANT JDR INTELIFUSE, INC. 13X10X10 1364/15

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTELIFUSER-2,| (B) (4), (AEON 10X10 IMPLANT)