BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCORPIOFLEX PS TIB INSERT

    MDR report key: 1051295 · Received May 22, 2008

    Report

    Report Number
    2249697-2008-00138
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    June 10, 2005
    Report Date
    April 10, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    K991461
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA COMPLICATION FORM COMPLETED ON (B) (6) 2007 BY SITE. CIRCUMSTANCES SURROUNDING ONSET OF EVENT WERE DESCRIBED AS "C/O BILATERAL CALF PAIN. WENT TO RHEUMATOLOGIST ON (B) (6) 2005. MRI SHOWED MINOR TRAUMA OR MUSCLE PULL TO THE LEFT CALF. NO ABNORMALITIES OBSERVED IN THE RIGHT CALF." SEVERITY WAS DESCRIBED AS "MILD" WITH A RELATION TO DEVICE OF "UNCERTAIN." EVENT WAS TREATED WITH ADVIL PRN ON (B) (6) 2005 AND REMAINED UNRESOLVED AS OF (B) (6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIOFLEX PS TIB INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA 98151501

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other