BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N-FORCE FC SCREW 4.0X45MM

    MDR report key: 8875338 · Received August 8, 2019

    Report

    Report Number
    0001056357-2019-00001
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    December 20, 2018
    Report Date
    August 8, 2019
    Manufacturer
    INNOVISION, INC.
    Product Code
    HWC
    PMA / PMN Number
    K151146
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# IN0502, LOT# 102154-0143, N-FORCE BLUE LARGE MIX SYSTEM; ITEM# IN0501, LOT# 102059-0117, N-FORCE BLUE 10CC. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, DUE TO THE POOR THREADS OF N-FORCE SCREW, AN ADDITIONAL SCREW DELIVERY SYSTEM AND BSM WERE USED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670441 N-FORCE FC SCREW 4.0X45MM SCREW, FIXATION HWC INNOVISION, INC. N/A 0006735

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention