MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INTERBODY INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	9734904
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.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 in a sacroiliac and thoracolumbar procedure.It was reported that pre-operatively the patient was diagnosed with degenerative scoliosis.After inserting the cage to the l2/3 level, the inserter was reattached for additional insertion and the insertion was attempted.But it did not move and the cage broke from the attachment part when hit with a hammer.The broken parts were collected and discarded due to blood contamination.The cage remained in the patient and was left as it was.There was no reported impact to the patient.Additional information was received stating that there was no plan from the site that a revision procedure would be performed.The fragment pieces remained at the implant level.

• Brand Name: INTERBODY INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13592284
• Report Number: 1723170-2022-00247
• Device Sequence Number: 5950378
• Product Code: MAX
• UDI-Device Identifier: 00763000208776
• UDI-Public: 00763000208776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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 Model Number: 9734904
• Device Catalogue Number: 9734904
• Device Lot Number: 9734456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female