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

Model Number 9734715

Device Problem Material Integrity Problem (2978)

Patient Problem Tissue Damage (2104)

Event Date 06/02/2019

Event Type  Injury  

Manufacturer Narrative

Patient information: not provided due to (b)(6) patient privacy regulations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a manufacturer representative (rep) regarding a navigation instrument being used for a sacroiliac and thoracolumbar procedure.The rep indicated that the surgeon commented that when attaching the spinous process clamp to a large spinous process it was very difficult to engage and did not attach well.Additionally, it was reported that the surgeon needed to take some of the spinous process away in order for the clamp to fit securely and allow for closure of the jaws.The site had to shave off some of the spinous process away in order to attach the clamp to complete the procedure.

• Brand Name: SPINOUS PROCESS TALL CLAMP
• 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: 8750688
• MDR Text Key: 149713441
• Report Number: 1723170-2019-03891
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9734715
• Device Catalogue Number: 9734715
• Device Lot Number: 180409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2018
• 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
• Patient Outcome(s): Required Intervention