BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR BOLT KIT, LSB STYLE

    MDR report key: 23037545 · Received September 12, 2025

    Report

    Report Number
    2183456-2025-00008
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    June 30, 2025
    Report Date
    September 25, 2025
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K223276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO LOT NUMBER OR GTIN WAS AVAILABLE, AS MULTIPLE ANCHOR BOLTS WERE PLACED DURING THE PROCEDURE, MAKING IT IMPOSSIBLE TO IDENTIFY THE SPECIFIC UNIT INVOLVED. THE PHYSICIAN HAS DECIDED NOT TO REMOVE THE RETAINED FRAGMENT. AD-TECH MEDICAL INSTRUMENT CORPORATION HAS COMMUNICATED WITH THE CUSTOMER VIA EMAIL REGARDING THE <30-DAY BIOCOMPATIBILITY OF THE ANCHOR BOLTS, CONFIRMING THAT THE MATERIAL IS SAFE FOR SHORT-TERM IMPLANTATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL FINDINGS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO LOT NUMBER OR GTIN WAS AVAILABLE, AS MULTIPLE ANCHOR BOLTS WERE PLACED DURING THE PROCEDURE, MAKING IT IMPOSSIBLE TO IDENTIFY THE SPECIFIC UNIT INVOLVED. THE PHYSICIAN HAS DECIDED NOT TO REMOVE THE RETAINED FRAGMENT. AD-TECH MEDICAL INSTRUMENT CORPORATION HAS COMMUNICATED WITH THE CUSTOMER VIA EMAIL REGARDING THE 30-DAY BIOCOMPATIBILITY OF THE ANCHOR BOLTS, CONFIRMING THAT THE MATERIAL IS SAFE FOR SHORT-TERM IMPLANTATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL FINDINGS BECOME AVAILABLE. REPORT #01 UPDATED 9/25/25 NO ADDITIONAL INFORMATION HAS BEEN SUBMITTED REGARDING THE REPORTED RETAINED ANCHOR BOLT. THE REPORTING PHYSICIAN HAS CONFIRMED AWARENESS OF THE BIOCOMPATIBILITY OF THE ANCHOR BOLT AND HAS ELECTED TO LEAVE THE COMPONENT IN PLACE. DUE TO THE ABSENCE OF TRACEABLE PRODUCT INFORMATION AND THE CLINICAL DECISION TO RETAIN THE DEVICE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. ACCORDINGLY, THIS COMPLAINT WILL BE CLOSED. SHOULD ANY NEW OR IDENTIFYING INFORMATION BECOME AVAILABLE, WE WILL REOPEN THE INVESTIGATION AS APPROPRIATE.

    Description of Event or Problem · 0

    DURING A ROUTINE SURGICAL PROCEDURE, THE LEFT TEMPORAL BOLT SHEARED OFF WHILE BEING REMOVED. A SMALL FRAGMENT OF THE BOLT WAS RETAINED IN THE PATIENT'S LEFT TEMPORAL BONE. THERE WAS NO IMPACT TO THE PATIENT NOR ANY DELAY IN THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS INCIDENT TO THE FDA ((B)(4)).

    Description of Event or Problem · 0

    DURING A ROUTINE SURGICAL PROCEDURE, THE LEFT TEMPORAL BOLT SHEARED OFF WHILE BEING REMOVED. A SMALL FRAGMENT OF THE BOLT WAS RETAINED IN THE PATIENT'S LEFT TEMPORAL BONE. THERE WAS NO IMPACT TO THE PATIENT NOR ANY DELAY IN THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS INCIDENT TO THE FDA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305694 ANCHOR BOLT KIT, LSB STYLE ANCHOR BOLT KIT, LSB STYLE GZL AD-TECH MEDICAL INSTRUMENT CORP. LSBK1-AX-? UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown