BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR BOLT

    MDR report key: 14414915 · Received May 17, 2022

    Report

    Report Number
    2183456-2022-00014
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    April 19, 2022
    Report Date
    August 5, 2022
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K181544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT REPORTED THAT THE ANCHOR BOLT WAS DISCOVERED BROKEN DURING ELECTRODE EXPLANT. AN ADDITIONAL SCAN WAS COMPLETED TO ASSESS THE BOLT AND IT WAS REMOVED SUCCESSFULLY. COMPLAINANT STATED THAT THIS ONLY ADDED AN ADDITIONAL 20-30 MINUTES TO THE PROCEDURE AND THE PATIENT WAS RELEASED NEXT DAY (STANDARD PROCEDURE). THIS PATIENT WAS REPORTED TO HAVING HAD EXTREMELY VIOLENT SEIZURES DURING MONITORING. NO SPECIFIC INFORMATION REGARDING THE ANCHOR BOLT CATALOG NUMBER, LOT, OR BATCH HAS BEEN RECEIVED BY THE USER FACILITY. THE ANCHOR BOLT HAS NOT YET BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    COMPLAINANT REPORTED THAT THE ANCHOR BOLT WAS DISCOVERED BROKEN DURING ELECTRODE EXPLANT. AN ADDITIONAL SCAN WAS COMPLETED TO ASSESS THE BOLT AND IT WAS REMOVED SUCCESSFULLY. COMPLAINANT STATED THAT THIS ONLY ADDED AN ADDITIONAL 20-30 MINUTES TO THE PROCEDURE AND THE PATIENT WAS RELEASED NEXT DAY (STANDARD PROCEDURE). THIS PATIENT WAS REPORTED TO HAVING HAD EXTREMELY VIOLENT SEIZURES DURING MONITORING. NO SPECIFIC INFORMATION REGARDING THE ANCHOR BOLT CATALOG NUMBER, LOT, OR BATCH HAS BEEN RECEIVED BY THE USER FACILITY. THE ANCHOR BOLT HAS NOT YET BEEN RETURNED. THE USER FACILITY WAS UNABLE TO PROVIDE TRACEABILITY INFORMATION FOR THE BOLT AND THE RETURN ANALYSIS WAS ALSO UNABLE TO IDENTIFY THE MODEL DUE TO SEPARATED COMPONENTS. THE ROOT CAUSE WAS INCONCLUSIVE AND MAY HAVE BEEN RELATED TO THE ANGLE OF THE BOLT IN THE SKULL. THE RISK ASSESSMENT CONCLUDED THAT THE CALCULATED OCCURENCE REMAINS ALAP AND NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    DURING EXPLANT OF ELECTRODES, AN ANCHOR BOLT WAS FOUND BROKEN IN THE SKULL. ADDITIONAL IMAGING AND PROLONGED PROCEDURE WAS NEEDED TO REMOVE THE ELECTRODE FROM THE SKULL. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    DURING EXPLANT OF ELECTRODES, AN ANCHOR BOLT WAS FOUND BROKEN IN THE SKULL. ADDITIONAL IMAGING AND PROLONGED PROCEDURE WAS NEEDED TO REMOVE THE ELECTRODE FROM THE SKULL. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395219 ANCHOR BOLT ANCHOR BOLT GZL AD-TECH MEDICAL INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other