MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2980001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent transforaminal lumbar interbody fusion due to degenerative disc disease.Intra-op, the implant was not able to load straight onto the inserter.Also, the implant could not be loaded securely onto inserter, it remained loose regardless of tightening.The product came in contact with the patient.There were no patient complications as a result of this event.

• Brand Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8292005
• Report Number: 1030489-2019-00099
• Device Sequence Number: 19255512
• Product Code: MAX
• UDI-Device Identifier: 00721902996689
• UDI-Public: 00721902996689
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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 Catalogue Number: 2980001
• Device Lot Number: PR12K013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1