MAUDE Adverse Event Report: STRYKER SPINE-US AVS ARIA 0DEGX18X45X10 CAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48750110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during lateral cage insertion, the cage broke.Another cage of the same size was used to successfully complete the procedure.The procedure was at the l2-l3 level ans insertion angle was noted difficult.All broken fragments were retrieved and no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via email correspondence with the sales rep.Device was returned for evaluation.It was found to have deformed threading area where the inserter is inserted.No manufacturing related issues were found upon device history review.Based on the information provided, the probable root cause of the reported event is difficult angle for insertion of the cage and excessive cantilever force applied during insertion.
Event or Problem Description
It was reported that during lateral cage insertion, the cage broke.Another cage of the same size was used to successfully complete the procedure.The procedure was at the l2-l3 level ans insertion angle was noted difficult.All broken fragments were retrieved and no reports of adverse consequences to the patient.

• Brand Name: AVS ARIA 0DEGX18X45X10 CAGE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7847792
• Report Number: 3005525032-2018-00055
• Device Sequence Number: 1565526
• Product Code: MAX
• UDI-Device Identifier: 07613252310518
• UDI-Public: 07613252310518
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: No Information
• Device Catalogue Number: 48750110
• Device Lot Number: ED6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/27/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1