BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5856300 · Received August 9, 2016

    Report

    Report Number
    2520274-2016-13975
    Event Type
    Injury
    Date Received
    August 9, 2016
    Report Date
    July 28, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. LITERATURE CITATION: KEENER, JAY D. M.D. AND DAHNERS, LAURENCE E. M.D. "PERCUTANEOUS PINNING OF DISPLACED MIDSHAFT CLAVICLE FRACTURES": TECHNIQUES IN SHOULDER AND ELBOW SURGERY 7(4): 175-181, 2006. UNITED STATES ARTICLE. THIS REPORT IS FOR UNKNOWN NAIL, UNKNOWN QUANTITY, UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, KEENER, JAY D. M.D. AND DAHNERS, LAURENCE E. M.D. "PERCUTANEOUS PINNING OF DISPLACED MIDSHAFT CLAVICLE FRACTURES": TECHNIQUES IN SHOULDER AND ELBOW SURGERY 7(4): 175-181, 2006. UNITED STATES ARTICLE. IN THIS ARTICLE, SURGICAL TECHNIQUE FOR ANTEROGRADE PINNING OF DISPLACED MIDSHAFT CLAVICLE FRACTURES WAS DISCUSSED. THE STUDY INCLUDED TWENTY FOUR (24) PATIENTS WITH DISPLACED CLAVICLE FRACTURES (OVER 3 YEARS) THAT WERE STABILIZED WITH A FLEXIBLE TITANIUM NAIL. THREE (3) PATIENTS WERE LOST TO FOLLOW UP. THE FOLLOWING ADVERSE EVENTS/COMPLICATIONS WERE NOTED. MALUNION (1 CASE OF DEVICE BACK-OUT AND REVISION, TWO (2) CASES OF DEVICE FAILURE/DEVICES BENT POST-OPERATIVELY). THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL (TEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515602 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention