MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SHORT DOUBLE SPINE CLAMP; INSTRUMENT, STEREOTAXIC

Model Number 9734724

Device Problems Difficult to Open or Close (2921); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

Patient info not known at the time of filing.Serial / udi / lot number not known at the time of filing.No device was returned to the manufacturer for analysis.Device manufacturing date not known at the time of filing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used during a procedure.It was reported that when the spine clamp was opened completely and was used, however it did not close well.The site decided to use another spine clamp to finish the procedure.There was no known delay to the procedure and no known impact on patient outcome.

Manufacturer Narrative

The returned clamp was analyzed and found to be in good condition with no apparent physical damage.No problems found it functions as designed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHORT DOUBLE SPINE CLAMP
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7997763
• MDR Text Key: 124824396
• Report Number: 1723170-2018-05313
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131425
• 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,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734724
• Device Catalogue Number: 9734724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1