BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, FIXATION, BONE

    MDR report key: 7152104 · Received December 28, 2017

    Report

    Report Number
    2939274-2017-50479
    Event Type
    Injury
    Date Received
    December 28, 2017
    Report Date
    December 1, 2017
    Manufacturer
    WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
    Product Code
    JDR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE EVENT OCCURRED. THIS REPORT IS FOR AN UNKNOWN SPEEDTRIAD STAPLE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE: 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT/EXPLANT DATES CAPTURED. 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 THAT THE PATIENT UNDERWENT REMOVAL OF A BROKEN BIOMEDICAL ENTERPRISES, INC. (BME) SPEEDTRIAD IMPLANT ON (B)(6) 2017. THE IMPLANT WAS ORIGINALLY IMPLANTED ON (B)(6) 2017 TO TREAT A FRACTURE OF A BUNIONECTOMY. THE PATIENT WAS NONCOMPLIANT AND WALKED ON HER FOOT AGAINST MEDICAL ADVISEMENT. THE IMPLANT WAS BROKEN IN HALF. THE PATIENT HAD PAIN AS A RESULT OF THE DEVICE FAILURE. THE BROKEN IMPLANT FRAGMENTS WERE EASILY REMOVED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED SATISFACTORILY. THIS COMPLAINT INVOLVES 1 (ONE) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931553 STAPLE, FIXATION, BONE JDR WRIGHTS LANE: SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention