MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SMALL ACTIVE FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733886

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to japanese patient privacy regulations.No parts have been received by the manufacturer for evaluation.Act.Part not returned for analysis.

Event Description

A site representative reported that, while in a spinal fusion, a led on the reference frame could not be recognized by the navigation system.The surgeon opted to complete the procedure without the use of the navigation system.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.

• Brand Name: SMALL ACTIVE FRAME
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7102845
• MDR Text Key: 94410254
• Report Number: 1723170-2017-05059
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000055134
• UDI-Public: 00763000055134
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733886
• Device Lot Number: 110708
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1