MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48824014
Medical Device Problem Code	Migration (4003)
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 screw.
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 screw.
Additional Manufacturer Narrative
Visually inspection: as all six of the bone screws were returned, it is unknown which screw migrated.The lot codes of three of the screws are illegible as the screw head surfaces are heavily scratched, the other three had lot# z7f.The square drive features of the screws are also worn.A review of the device and complaint history records could not be performed as a valid lot code could not be obtained.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/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 screw.
Additional Manufacturer Narrative
The device has been returned and the record has been updated to reflect that.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10142792
• Report Number: 0009617544-2020-00085
• Device Sequence Number: 3468847
• Product Code: KWQ
• UDI-Device Identifier: 07613252152606
• UDI-Public: 07613252152606
• 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: 48824014
• Device Catalogue Number: 48824014
• Device Lot Number: UNKNOWN
• 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: 06/11/2020
• 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