BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIBRIDGE ACP DRILL

    MDR report key: 8374661 · Received February 27, 2019

    Report

    Report Number
    3009446038-2019-00001
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    October 4, 2018
    Report Date
    February 18, 2019
    Manufacturer
    NANOVIS LLC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S OUTCOME WAS GOOD WITH NO ANTICIPATED NEGATIVE EFFECTS RELATED TO THE EVENT. A REVIEW OF MANUFACTURING HISTORY SHOWS PRODUCT WAS RELEASED WITHOUT ANOMALY. A REVIEW OF COMPLAINT HISTORY SHOWS NO OTHER COMPLAINTS FOR THIS PART NUMBER OR LOT NUMBER. ENGINEER EVALUATION SHOWS THE FRACTURE SURFACE APPEARS TO BE CONSISTENT WITH A TORSIONAL LOAD FRACTURE. RISK IS ADDRESSED THROUGH IFU AND SURGICAL TECHNIQUE. NANOVIS IS CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS. WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (C4-C7) PROCEDURE ON (B)(6) 2018 A 10 MM DRILL BIT TIP FRACTURED IN A PATIENT'S BONE. THE DRILL BIT WAS FOUND ON X-RAYS THAT WERE TAKEN AFTER IMPLANTATION, DURING THE PROCEDURE. THE SURGEON RETRIEVED THE TIP OF THE DRILL BIT AND REPLACED HARDWARE, THUS CAUSING A 30 MINUTE DELAY IN THE COMPLETION OF THE PROCEDURE. THE PATIENT'S OUTCOME WAS GOOD WITH NO ANTICIPATED NEGATIVE EFFECTS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166840 FORTIBRIDGE ACP DRILL FORTIBRIDGE ACP DRILL LXH NANOVIS LLC 00798-0010 NG75618

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention