MAUDE Adverse Event Report: STRYKER SPINE-US AVS ARIA 8DEGX22X50X12 CAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48753212
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in the or, a cage was loaded onto the inserter.It was noticed by the surgeon that the anterior / posterior markers were on the wrong/opposite sides of the cage.There are no reports of adverse consequences to the patient.
Event or Problem Description
It was reported that while in the or, a cage was loaded onto the inserter.It was noticed by the surgeon that the anterior / posterior markers were on the wrong/opposite sides of the cage.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Method: a video clip device history review, complaint history review, risk assessment.Results/conclusion: the reported laser marking error was confirmed via a video clip of the device sent to post market surveillance.The device was not returned.The event did not result in any patient's harm.A non conformance was opened to further investigate this issue.A commercial hold has been placed on the affected items and the product in the warehouse was scraped.A change control has been open to add a laser marking inspection before product release.Capa was open to evaluate how to avoid a reoccurrence of this issue and to continue the investigation regarding the laser marking process.

• Brand Name: AVS ARIA 8DEGX22X50X12 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: 7615996
• Report Number: 3005525032-2018-00042
• Device Sequence Number: 1317425
• Product Code: MAX
• UDI-Device Identifier: 07613252311478
• UDI-Public: (01)07613252311478
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101051
• 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): 08/20/2018

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 Model Number: 48753212
• Device Catalogue Number: 48753212
• Device Lot Number: 7HX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1