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

Catalog Number LSBK1-BX-05; LSBK1-AX-05

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2021

Event Type  malfunction  

Manufacturer Narrative

A user facility medwatch form 3500a (uf# (b)(4)) was also submitted by the customer.This report was received by ad-tech the week of april 5, 2021.

Event Description

Upon removal of the anchor bolts from the patient in a case from (b)(6) 2021, fragments of the bolts were discovered as being retained on the ct scan.Additional medical intervention was needed to remove the bolt fragments; however, there is no indication that there was impact to the patient.

• Brand Name: LSB STYLE ANCHOR BOLT
• Type of Device: LSB STYLE ANCHOR BOLTS
• 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: kathleen barlow ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 11672524
• MDR Text Key: 247926247
• Report Number: 2183456-2021-00003
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

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 Catalogue Number: LSBK1-BX-05; LSBK1-AX-05
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/15/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR