BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONICAL SUBTALAR IMPLANT (CSI)

    MDR report key: 665322 · Received January 16, 2006

    Report

    Report Number
    2030833-2006-00003
    Event Type
    Other
    Date Received
    January 16, 2006
    Date of Event
    December 2, 2005
    Report Date
    January 16, 2006
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REQUESTED BOTH SUBTALAR IMPLANTS TO BE REMOVED DUE TO PAIN. DEVICES WERE IMPLANTED ON SEPARATE OCCASSIONS, BUT WERE BOTH REMOVED DURING ONE PROCEDURE. TWO REPORTS WRITTEN AS TWO DEVICES WERE REMOVED. REFER TO 2030833-2006-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONICAL SUBTALAR IMPLANT (CSI) SUBTALAR ARTHRORESIS IMPLANT HWC NEXA ORTHOPEDICS, INC. CSI-11 L07402

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR