MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERCUTANEOUS SPINE REFERENCE FRAME; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	9732353
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument has not been returned to medtronic for analysis.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the percutaneous spine reference frame was damaged.There was no patient involved.
Additional Manufacturer Narrative
A manufacturing representative went to the site to analyze the instrument and noted that none of the teeth on the instrument were loose, but one tooth was slightly bent from use.It was noted that there was not enough damage to warrant a new instrument.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received clarifying the event.The concern was with a reference frame post teeth being bent.The site has continued to use the reference frame post for several more cases.

• Brand Name: PERCUTANEOUS SPINE REFERENCE FRAME
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9180346
• Report Number: 1723170-2019-05195
• Device Sequence Number: 3447845
• Product Code: MAX
• UDI-Device Identifier: 00613994151179
• UDI-Public: 00613994151179
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: 9732353
• Device Catalogue Number: 9732353
• Device Lot Number: 080717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1