MAUDE Adverse Event Report: STRYKER SPINE-US AERO C CAGE 7MM INTERBODY DEVICE, 12DX14W LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	48892076
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Tingling (2171)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device still in the patient.
Event or Problem Description
It was reported that the cage started backing out post-operatively.Implant is still in the patient and experienced slight pain and slight tingling in finger.Per the communication with sales rep., x- ray image review which was taken (b)(6) 2019 revealed that cage( pin) had not backed out further.Currently, no revision surgery has been planned.
Event or Problem Description
It was reported that the cage started backing out post-operatively.Implant is still in the patient and experienced slight pain and slight tingling in finger.Per the communication with sales rep., x- ray image review which was taken (b)(6) 2019 revealed that cage( pin) had not backed out further.Currently, no revision surgery has been planned.
Additional Manufacturer Narrative
Method: product history review, complaint history review, labelling review and risk assessment.Dimensional, functional and materials analysis could not be performed as the device remains implanted in patient.Results: the customer reported event of a cage anchor migration post-op was confirmed via x-ray images review.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.No similar complaints for the reported lot number were identified.Conclusion: based on the x-ray image review, the migrated anchor was not fully locked; therefore, the root cause of the reported anchor migration is due to user's deviation of surgical technique.Per surgical technique "step - anchor channel and insertion:.Visually confirm and use lateral fluoroscopic images to verify that the anchors are flush with the jacket.If the anchor is not locked to the jacket, the anchor will protrude approximately 1.25 mm anteriorly.If after removing the implant inserter and anchor tamp, the anchor still appears proud, use the tamp for final placement.Place distal end of tamp against the superior dovetail and tap with mallet to ensure the anchor is fully seated.".

• Brand Name: AERO C CAGE 7MM INTERBODY DEVICE, 12DX14W LORDOTIC
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8383672
• Report Number: 0009617544-2019-00019
• Device Sequence Number: 18910374
• Product Code: ODP
• UDI-Device Identifier: 07613327124668
• UDI-Public: 07613327124668
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 48892076
• Device Lot Number: 161262
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1