BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSB ANCHOR BOLT

    MDR report key: 12708001 · Received October 27, 2021

    Report

    Report Number
    2183456-2021-00013
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 27, 2021
    Report Date
    June 15, 2022
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K181544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED 6/15/2022. IT WAS CONFIRMED BY THE PHYSICIAN THAT THE ANCHOR BOLT WAS SUCCESSFULLY REMOVED WITHOUT PATIENT HARM DURING THE ROUTINE NEUROMONITORING EXPLANT PROCEDURE. PER THE RISK ASSESSMENT, THE CALCULATED OCCURRENCE MATCHES THE OCCURRENCE LEVEL PRESENT IN THE RISK FILE AND THE RESULTING RISK LEVEL WILL REMAIN "ALAP" (AS LOW AS POSSIBLE). NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    WE RECEIVED A REPORT THAT AN ANCHOR BOLT BROKE IN A PATIENT'S HEAD. THERE WAS NO REPORT OF A SERIOUS INJURY.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AN ANCHOR BOLT BROKE IN A PATIENT'S HEAD. THERE WAS NO REPORT OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605025 LSB ANCHOR BOLT ANCHOR BOLT GZL AD-TECH MEDICAL INSTRUMENT CORP. LSB ANCHOR BOLT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown