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

Model Number LSB ANCHOR BOLT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/27/2021

Event Type  malfunction  

Event Description

We received a report that an anchor bolt broke in a patient's head.There was no report of a serious injury.

Manufacturer Narrative

Updated 6/15/2022.It was confirmed by the physician that the anchor bolt was successfully removed without patient harm during the routine neuromonitoring explant procedure.Per the risk assessment, the calculated occurrence matches the occurrence level present in the risk file and the resulting risk level will remain "alap" (as low as possible).No further action is needed at this time.

Event Description

We received a report that an anchor bolt broke in a patient's head.There was no report of a serious injury.

• 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: nicole remer ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 12708001
• MDR Text Key: 278871545
• Report Number: 2183456-2021-00013
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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
• Device Model Number: LSB ANCHOR BOLT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 06/15/2022
• 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