MAUDE Adverse Event Report: MONTERIS MEDICAL INC. AXIIIS STEREOTACTIC MINIFRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number AX300-01

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 01/27/2016

Event Type  malfunction  

Event Description

According to the surgeon, a screw was placed and tighten down in the axis frame and broke off.

• Brand Name: AXIIIS STEREOTACTIC MINIFRAME
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MONTERIS MEDICAL INC.; 14755 27th ave n ste. c; plymouth MN 55446
• MDR Report Key: 5623613
• MDR Text Key: 44139309
• Report Number: 5623613
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2016,04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AX300-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 91