BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN TO ROD COUPLING HOFFMANN II 8/4-5MM

    MDR report key: 1641519 · Received March 23, 2010

    Report

    Report Number
    8031020-2010-00034
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 1, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JEC
    PMA / PMN Number
    K952730
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEMS LISTED IN THE PER (B)(4) ARE NOT MRI CONDITIONAL. THE FOLLOWING CORRESPONDING ITEMS ARE MRI CONDITIONAL: (B)(4), AND (B)(4). THIS IS WHAT THEY SHOULD HAVE USED. MRI ITEMS ARE ALWAYS A DIFFERENT COLOR (GREEN WITH YELLOW BOLTS) AND HAVE "MRI" PRINTED ON THE DEVICES. THIS IS DESCRIBED IN THE HOFFMANN II MRI BROCHURE. DUE TO THE ABOVE MENTIONED REASON, THE COMPLAINT ISSUE IS NOT CONSIDERED TO BE DEVICE RELATED (USAGE BEYOND THE INTENDED USE). PLEASE NOTE THE FOLLOWING INFORMATION FROM THE PRODUCT BROCHURE HOFFMANN II MRI EXTERNAL FIXATION SYSTEMS (B)(4) FOR THIS REASON, STRYKER OFFERS A LINE EXTENSION OF EXTERNAL FIXATION WHICH MAY BE USED SAFELY IN MRI SCANNERS UP TO 3.0 (B)(4). THIS MEANS THAT THE PATIENT CAN BE PLACED IN THE MRI SCANNER WITH THE FIXATOR IN SITU WITHOUT ADDITIONAL RISK FOR THE PATIENT OR THE MRI SCANNER ITSELF.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE, DOCTOR INDICATED THAT ALL PRODUCTS, IMPLANTS AND EX FIX WERE MRI SAFE. PATIENT ENTERED THE MRI FIELD AND THE MACHINE GRABBED HIS LEG BY MAGNETIC FORCE AND JERKED IT UPWARD. PATIENT EXPERIENCED SEVERE PAIN. PATIENT WAS NOT PUT ALL THE WAY INTO THE MACHINE AT THAT TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN TO ROD COUPLING HOFFMANN II 8/4-5MM IMPLANT JEC STRYKER OSTEOSYNTHESIS SELZACH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other