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

Model Number	LSBK1-AX=05
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 ad-tech's (b)(6) distributor sent a report from a customer about an issue that occurred on (b)(6) 2017.It was reported that during placement, an anchor bolt broke and a piece remained in the patient's skull.The remaining piece was removed during an additional procedure and there was no harmful impact to the patient.

• Brand Name: LSB ANCHOR BOLT
• Common Device Name: ANCHOR BOLT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 12526153
• Report Number: 2183456-2021-00010
• Device Sequence Number: 4031740
• Product Code: GZL
• UDI-Device Identifier: 00841823104267
• UDI-Public: (01)00841823104267(17)190901(10)0113052208140653
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: LSBK1-AX=05
• Device Catalogue Number: LSBK1-AX-05
• Device Lot Number: 0113052 208140653
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1