BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: RAFN

    MDR report key: 11330204 · Received February 15, 2021

    Report

    Report Number
    8030965-2021-01024
    Event Type
    Injury
    Date Received
    February 15, 2021
    Report Date
    January 27, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - SCREWS: SPINE/UNKNOWN LOT. PART AND LOT NUMBERS 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: REYNDERS, P. (2013), NEW MODULAR FEMORAL NAILS, DOES IT MATTER? INJURY, VOL. 44 (S2), PAGES S20 (BELGIUM). THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO EVALUATE THE OUTCOME VARIABLES IN THE THREE COHORTS OF PATIENTS¿ GROUPS WITH ADULT FEMORAL FRACTURES. A TOTAL OF 145 PATIENTS WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING UFN IN 53 PATIENTS, RFN IN 54, AND ELFN IN 38. THE FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED: UFN GROUP: 5 PATIENTS HAD IMPLANT FAILURE. 4 PATIENTS HAD DELAYED UNION. RFN GROUP: 3 PATIENTS HAD DELAYED UNION. ELFN GROUP: 2 PATIENTS HAD DELAYED UNION. THIS REPORT IS FOR AN UNKNOWN SYNTHES UNREAMED FEMORAL NAIL CONSTRUCTS, UNKNOWN SYNTHES RETROGRADE FEMORAL NAIL CONSTRUCTS, AND UNKNOWN SYNTHES EXPERT FEMORAL NAIL CONSTRUCTS. THIS REPORT IS FOR (1) UNK - CONSTRUCTS: RAFN. THIS IS REPORT 2 OF 3 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223201 UNK - CONSTRUCTS: RAFN NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention