BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM HEADLESS COMPRESSION SCREW/LONG THREAD/60MM

    MDR report key: 3912884 · Received July 3, 2014

    Report

    Report Number
    3009450884-2014-10032
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK080943
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 DURING A FUSION PROCEDURE A 4.5MM HEADLESS COMPRESSION SCREW UNRAVELED AT THE THREADS AND A K-WIRE THAT WAS PUSHING THROUGH THE JOINT WAS REMOVED. SURGEON USED AN OSTEOTOME TO REMOVE BROKEN HARDWARE. THE SURGEON WAS ABLE TO RETRIEVE ALL PIECES. THERE WAS A SURGICAL DELAY REPORTED OF TWENTY MINUTES. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390979 4.5MM HEADLESS COMPRESSION SCREW/LONG THREAD/60MM SCREW,FIXATION,BONE HWC SYNTHES GRENCHEN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention