BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR BOLT - LSB STYLE

    MDR report key: 6936461 · Received October 10, 2017

    Report

    Report Number
    2183456-2017-00009
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 28, 2017
    Report Date
    October 9, 2017
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORPORATION
    Product Code
    GCZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE EVENT DESCRIPTION, AD-TECH WAS MADE AWARE OF AN ISSUE VIA EMAIL ON (B)(6) 2017. THE EMAIL STATED THAT AN ANCHOR BOLT WAS FOUND TO BE BROKEN AND THE END REMAINS IN SITU IN THE PATIENT'S SKULL. THE BOLT WAS FRACTURED UPON REMOVAL. THE CAP WAS ESSENTIALLY HELD PROXIMATE TO THE INTRACRANIAL BOLT REMNANT BY THE INDWELLING ELECTRODE. UPON REMOVAL OF THE ELECTRODE, THE CAP AND PROXIMAL END OF THE ANCHOR BOLT WERE FREED. THE TEAM OPTED TO LEAVE THE BOLT FRAGMENT IN SITU AS THIS BOLT WAS IN THE RIGHT OCCIPITAL REGION, IN THE EXPECTED SURGICAL FIELD OF ANY RESECTION. THE BOLT FRAGMENT MAY BE RETRIEVED SHOULD THE PATIENT COME TO CRANIOTOMY. ACCORDING TO THE DOCTOR, THE PATIENT WAS RESTRICTED TO BED FOR MOST OF 7 DAYS, HAD EXCLUSIVELY NON-CONVULSIVE PARTIAL SEIZURES, AND NO APPARENT TRAUMA OR VOLITIONAL MANIPULATION UPON REVIEW OF VIDEO. THE PRODUCT WAS NOT SENT BACK TO AD-TECH FOR EVALUATION. INSTEAD, A PICTURE WAS SENT SHOWING THE BROKEN BOLT. BASED ON THE PICTURE, THE ALLEGED DEFICIENCY IN THE COMPLAINT WAS CONFIRMED. THIS INVESTIGATION IS STILL ON-GOING.

    Description of Event or Problem · 1

    AD-TECH RECEIVED AN EMAIL FROM A REPRESENTATIVE AT (B)(6) ON (B)(6) 2017 STATING THAT AN ANCHOR BOLT WAS FOUND TO BE BROKEN AND THE END REMAINS IN SITU IN THE PATIENT'S SKULL. THE BOLT HAD FRACTURED UPON REMOVAL. THE CAP WAS HELD PROXIMATE TO THE INTRACRANIAL BOLT REMNANT BY THE INDWELLING ELECTRODE. UPON REMOVAL OF THE ELECTRODE, THE CAP AND PROXIMAL END OF THE ANCHOR BOLT WERE FREED. THE TEAM OPTED TO LEAVE THE BOLT FRAGMENT IN SITU AS THIS BOLT WAS IN THE RIGHT OCCIPITAL REGION, IN THE EXPECTED SURGICAL FIELD OF ANY RESECTION. THE PATIENT WAS RESTRICTED TO BED FOR MOST OF 7 DAYS AND HAD EXCLUSIVELY NON-CONVULSIVE PARTIAL SEIZURES. ACCORDING TO THE CUSTOMER, THERE WAS NO APPARENT TRAUMA OR VOLITIONAL MANIPULATION TO THE PATIENT UPON REVIEW OF THE VIDEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713355 ANCHOR BOLT - LSB STYLE ANCHOR BOLT-LSB STYLE GCZ AD-TECH MEDICAL INSTRUMENT CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other