BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, FIXATION, BONE

    MDR report key: 6607646 · Received June 2, 2017

    Report

    Report Number
    1649263-2017-10012
    Event Type
    Injury
    Date Received
    June 2, 2017
    Report Date
    May 5, 2017
    Manufacturer
    BIO MEDICAL ENTERPRISES INC
    Product Code
    JDR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN BME IMPLANT /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD BEEN IMPLANTED WITH BME (BIO MEDICAL ENTERPRISE) IMPLANT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT DEVELOPED AN ALLERGY TO NITINOL (NICKEL-TITANIUM ALLOY).THE IMPLANT WAS REMOVED ON AN UNKNOWN DATE. PATIENT INFORMATION AND STATUS IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN BME IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389336 STAPLE, FIXATION, BONE JDR BIO MEDICAL ENTERPRISES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention