MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 26; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811226
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an aviator screw migrated out of a deformed aviator assy two level plate post-operatively.The patient was experiencing dysphagia and the surgeon noticed the screw had migrated via x-ray imaging.Revision surgery was performed and the screw and plate were replaced.This report represents the plate.
Additional Manufacturer Narrative
The device has been returned and the record has been updated to reflect that.
Event or Problem Description
It was reported that an aviator screw migrated out of a deformed aviator assy two level plate post-operatively.The patient was experiencing dysphagia and the surgeon noticed the screw had migrated via x-ray imaging.Revision surgery was performed and the screw and plate were replaced.This report represents the plate.
Additional Manufacturer Narrative
Visual inspection: it was confirmed that the aviator plate had spring bar damage.However, it is inconclusive which areas were damaged due to revision surgery and which areas contributed to the failure mode.The wings of middle spring bar are dislocated from its intended position and lift away from the plate.The inferior most spring bar has been removed.Discoloration can also be seen throughout the plate.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Correspondence with rep confirms that the bone screws were seated below the spring bar in locked position and were not over-angulated during index surgery.However, bone prep and insertion method, patient activity level and occurrence of fusion are all unknown.X-ray images were not available for review.The root cause of this event could not be determined conclusively from the available information.
Event or Problem Description
It was reported that an aviator screw migrated out of a deformed aviator assy two level plate post-operatively.The patient was experiencing dysphagia and the surgeon noticed the screw had migrated via x-ray imaging.Revision surgery was performed and the screw and plate were replaced.This report represents the plate.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 26
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10141152
• Report Number: 0009617544-2020-00084
• Device Sequence Number: 2115563
• Product Code: KWQ
• UDI-Device Identifier: 07613252152170
• UDI-Public: 07613252152170
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2020

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 Model Number: 48811226
• Device Catalogue Number: 48811226
• Device Lot Number: 11A005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 07/31/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/10/2020; 08/27/2020
• 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: Required Intervention
• Patient Age: 57 YR