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

Catalog Number SEE H.10 FOR INFORMATION

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Impacted devices: lsbk1-ax-05, lot 732733734, expiration 01/01/2022, udi (b)(4).Lsbk1-bx-05, lot 735736737, expiration 03/01/2022, udi (b)(4).The preliminary risk assessment was conducted for this issue on 10-8-2020.According to the assessment anchor bolts were placed without issue.Eeg signals were monitored and the patient experienced only non-violent seizures.Anchor bolts were found broken when removing the dressing from the patient's head after monitoring without a known cause.Additional actions were taken to remove the anchor bolts from the skull, so mechanical energy.Damage to healthy tissue, severity 4, is the most applicable potential harm.The patient was reported as okay following the removal.

Event Description

During removal of the patient's head dressing it was discovered that the anchor bolts had broken off at the skull.The retained threads were surgically removed without further harm to the patient.

• Brand Name: LSB ANCHOR BOLT
• Type of Device: 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: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 10652150
• MDR Text Key: 238830639
• Report Number: 2183456-2020-00025
• 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: Physician
• Type of Report: Initial
• Report Date: 10/08/2020

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: SEE H.10 FOR INFORMATION
• Device Lot Number: SEE H.10 FOR INFORMATION
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2020
• 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