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

Model Number LSBK1-AX=05

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2017

Event Type  malfunction  

Event 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
• 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: erika keller ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 12526153
• MDR Text Key: 273123695
• Report Number: 2183456-2021-00010
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00841823104267
• UDI-Public: (01)00841823104267(17)190901(10)0113052208140653
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No
• 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