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

Model Number LS8KI-BX-05

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2021

Event Type  Injury  

Event Description

Patient had deep brain electrodes placed.On removal, fragments of the electrode bolts were discovered as being retained on ct scan.Manufacturer was ad-tech and product ref # (b)(4).

• Brand Name: LSB DEPTH ELECTRODE ANCHOR BOLTS
• Type of Device: ELECTRODE, DEPTH
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 11581435
• MDR Text Key: 242700121
• Report Number: 11581435
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LS8KI-BX-05
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17155 DA