MAUDE Adverse Event Report: BRAINLAB AG BRAINLAB NAVIGATION SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

During craniotomy, c1 drill bit used.Noted this was placed into the b1 guard.Designs/coloration of bits and guards are very similar.A piece of the bit was found to be retained on post-op mri and required wound to be washed out and drill bit removed.

• Brand Name: BRAINLAB NAVIGATION SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BRAINLAB AG; 5 westbrook corporate ctr ste 1000; westchester IL 60154
• MDR Report Key: 18290797
• MDR Text Key: 330043529
• Report Number: 18290797
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15330 DA
• Patient Sex: Female
• Patient Race: White