MAUDE Adverse Event Report: PRO MED INSTRUMENTS, INC., SALES AND SERVICE CENTE DORO MOUNT HEAD FRAME; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2013

Event Type  Injury  

Event Description

A medtronic representative reported during a cranial procedure, the surgeon was inaccurate.It was determined that the inaccuracy was caused because the doro head frame, to which the patient reference frame was attached, had moved.The surgeon chose to abort navigation instead of reregistering.After the case it was determined that the issue was a set up problem with a new fellow.He did not lock the head frame during setup for the case causing the head to move.Several attempts have been made by medtronic reps to provide proper equipment setup however the attempts have been declined.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DORO MOUNT HEAD FRAME
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): PRO MED INSTRUMENTS, INC., SALES AND SERVICE CENTE
• MDR Report Key: 17537454
• MDR Text Key: 321162792
• Report Number: MW5144332
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1