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

Model Number 9734715

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

Device lot number unavailable.No parts have been returned for analysis.No results possible.Device manufacturing date is dependent on lot number, therefore, unavailable.Second spinous process clamp tall reported in forthcoming regulatory reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system event having occurred outside of procedure.It was reported that the site had two spine clamps that were damaged and would not open.No patient present.

Manufacturer Narrative

Hardware analysis determined that the retainer ring on the tip of the adjustment screw is missing.The adjustment screw had been backed out too far forcing the retainer ring free.The clamp is in otherwise good condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPINOUS PROCESS CLAMP TALL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 8201355
• MDR Text Key: 131592994
• Report Number: 1723170-2018-06472
• Device Sequence Number: 1
• Product Code: OLO
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734715
• Device Catalogue Number: 9734715
• Device Lot Number: 160707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2016
• 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