BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR BOLT - LSB STYLE

    MDR report key: 7022990 · Received November 10, 2017

    Report

    Report Number
    2183456-2017-00010
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Report Date
    November 10, 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, (B)(6) FROM (B)(6) CONTACTED AD-TECH BY EMAIL ON (B)(6) 2017 REGARDING ANCHOR BOLTS THAT BROKE. TWO FRACTURED ANCHOR BOLTS WERE PARTIALLY RETRIEVED ON AN EXPLANT. THIS WAS A PATIENT WITH NON-CONVULSIVE SEIZURES, AND NO OVERT TRAUMA IN THE EMU OR THEATRE. ONE BOLT WAS SUBSEQUENTLY RETRIEVED AT CRANIOTOMY, ANOTHER, IN AN UNINVOLVED REGION, REMAINS IN SITU. THE PRODUCTS WERE NOT SENT BACK TO AD-TECH FOR EVALUATION. INSTEAD, A PICTURE WAS SENT SHOWING THE BROKEN BOLTS. BASED ON THE PICTURE, THE ALLEGED DEFICIENCY IN THE COMPLAINT WAS CONFIRMED. THE INVESTIGATION IN STILL ON-GOING.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A CUSTOMER CONTACTED AD-TECH VIA EMAIL REGARDING ANCHOR BOLTS THAT BROKE. IT WAS STATED THAT TWO FRACTURED ANCHOR BOLTS WERE PARTIALLY RETRIEVED ON AN EXPLANT. THIS WAS A PATIENT WITH NON-CONVULSIVE SEIZURES, AND NO OVERT TRAUMA IN THE EMU OR THEATRE. THE CUSTOMER ALSO STATED THAT ONE BOLT WAS SUBSEQUENTLY RETRIEVED AT CRANIOTOMY. ANOTHER ONE, IN AN UNINVOLVED REGION, REMAINED IN SITU. THERE IS NO KNOWN IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801534 ANCHOR BOLT - LSB STYLE ANCHOR BOLT - LSB STYLE GCZ AD-TECH MEDICAL INSTRUMENT CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other