MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. ANCHOR BOLT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

It was reported that a bolt in the temporal region broke off.The doctor believes that he collected all of it, but when he brings the patient in to remove all of the bolts and elecrodes, he will investigate the site to ensure it is completely removed.

Event Description

On august 8, 2022, an email was received reporting that an anchor bolt had broken off in the temporal region.

Event Description

On (b)(6) 2022, an email was received reporting that an anchor bolt had broken off in the temporal region.

Manufacturer Narrative

It was reported that a bolt in the temporal region broke off.The doctor believes that he collected all of it, but when he brings the patient in to remove all of the bolts and electrodes, he will investigate the site to ensure it is completely removed.Updated: 11/18/2022: the user facility was not able to provide traceability information for the bolt (no catalog number, lot number, or batch number) and the return analysis was also not able to identify the model due to only the top portion and cap being returned.There was a clear break in the threading of the bolt, but the root cause was inconclusive.There was no report of harm or impact to the patient.The risk assessment concluded that the calculated occurence remains "alap" (as low as possible) and no further action is needed at this time.

• Brand Name: ANCHOR BOLT
• Type of Device: ANCHOR BOLT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: nicole remer ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 15324537
• MDR Text Key: 305375174
• Report Number: 2183456-2022-00016
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other