MAUDE Adverse Event Report: BRAINLAB AG CURVE NAVIGATION 17710; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 17710

Device Problem Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  Death  

Event Description

Discovered screw was placed in t1 instead of c7 per md "due to inaccuracy of image guidance system".An expert from brain lab came on site to evaluate the device with a mock surgery and stated "workflow error not software error.

• Brand Name: CURVE NAVIGATION 17710
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BRAINLAB AG; 5 westbrook corporate ctr ste 1000; westchester IL 60154
• MDR Report Key: 12932980
• MDR Text Key: 281738179
• Report Number: 12932980
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2021
• Date Report to Manufacturer: 12/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 22991 DA