MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FRAME REF SM PASSIVE SP; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 9730605

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis on the returned small reference frame resulted in no failure being found.Analysis stated that the returned frame is faded with many nicks and scratches, but is in good working condition.With markers attached and fully seated, the frame returns good geometry and divot error readings.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of procedure.It was reported that the site had discovered damaged instruments during sterile processing.The was noted that the probes are bent, the clamp screw is stripped and the reference frame is bent.There was no patient present when this issue was identified.

• Brand Name: FRAME REF SM PASSIVE SP
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 8028996
• MDR Text Key: 125833480
• Report Number: 1723170-2018-05438
• Device Sequence Number: 1
• Product Code: MAX
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9730605
• Device Catalogue Number: 9730605
• Device Lot Number: 399856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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