MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST 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 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Part has not been returned for analysis.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 a procedure.It was reported that the spine reference had a defect and was unusable.There was no patient present when this issue was observed.

Manufacturer Narrative

Additional information: it was reported that the sites navigation system couldn¿t track the spine clamp.There was no obvious damage visible but a second spine clamp worked normally.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INST 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: 8117522
• MDR Text Key: 128872938
• Report Number: 1723170-2018-05947
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00721902812743
• UDI-Public: 00721902812743
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• 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: 120524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1