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

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

The removal of the anchor bolt was confirmed by extra x-rays.

Event Description

Upon the removal of the head wrap the surgeon noted that an anchor bolt was broken.Additional medical intervention was needed to remove the bolt; however there was no harm or injury to the patient.

Manufacturer Narrative

The removal of the anchor bolt was confirmed by extra x-rays.Updated 12/6/2023.The product was returned for evaluation.The alleged complaint was confirmed that the anchor bolt was broken.The anchor bolt broke at the point it was designed to break.Breaking can occur from many things like excessive force when tightening, patient movement (seizures) during monitoring, etc.It is unclear at what point in time the anchor bolt broke as it was not discovered until the removal of the head wrap.No root cause can be positively identified of the return or the information supplied.The calculated occurrence level matches the occurrence level present in the risk file and the resulting risk level will remain "alap".No further action is needed at this time.

Event Description

Upon the removal of the head wrap the surgeon noted that an anchor bolt was broken.Additional medical intervention was needed to remove the bolt; however there was no harm or injury to the patient.

• Brand Name: LSB STYLE ANCHOR BOLT
• Type of Device: LSB STYLE 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: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 18102264
• MDR Text Key: 327774487
• Report Number: 2183456-2023-00008
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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?: No
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1