ANCHOR BOLT KIT, LSB STYLE

Additional Manufacturer Narrative

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.

Description of Event or Problem

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)).

Additional Manufacturer Narrative

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

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).