MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS TALL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734715

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Device lot number unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system.It was reported that during a procedure the long spine clamp was not holding adequately.It was noted that this clamp was from one of their older trays, around 5-6 years old.There was no reported impact to the patient.No additional information was provided.

• Brand Name: CLAMP, SPINOUS PROCESS TALL
• Type of Device: ORTHOPEDIC 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7661048
• MDR Text Key: 113175476
• Report Number: 1723170-2018-03135
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169936300
• UDI-Public: 00643169936300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734715
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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