MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ARTIC-L 3D TI SPINAL SYSTEM WITH TIONIC TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	56251005
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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
Pre op diagnosis: infection procedure performed: cage removal and autogenous bone graft was performed levels implanted: l5/s post op, cage backed out and patient suffered infection.Although it was unknown if the cause of infection was cage backing out.As a result additional surgery was performed, the cage was removed and washed, and autogenous bone graft was performed.

• Brand Name: ARTIC-L 3D TI SPINAL SYSTEM WITH TIONIC TECHNOLOGY
• 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: 10104372
• Report Number: 1030489-2020-00566
• Device Sequence Number: 11439873
• Product Code: MAX
• UDI-Device Identifier: 00763000085445
• UDI-Public: 00763000085445
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 56251005
• Device Lot Number: CA19A007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 86