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	Injury (2348)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been explanted but will not be returned.
Event or Problem Description
It was reported that the retaining spring of an aviator assy three level plate broke and two aviator variable self drilling screws backed out post-operatively.Revision surgery has occurred and the two screws have been removed.The plate remains implanted.This report will capture the first of two screws.
Event or Problem Description
It was reported that the retaining spring of an aviator assy three level plate broke and two aviator variable self drilling screws backed out post-operatively.Revision surgery has occurred and the two screws have been removed.The plate remains implanted.This report will capture the first of two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The hardware was implanted for approximately a year.Per the surgical technique, aviator devices are indicated for treatment of fracture or stabilization of a surgical site during the normal bone consolidation process.Patients involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) may be at increased risk for failure of the fusion and/or the device.Surgeons must instruct patients in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly.The procedure will not restore function to the level expected with a normal, healthy spine, and surgeons should counsel patient to not have unrealistic functional expectations.Since devices were not returned for evaluation and no x-rays were provided the root cause of the reported event cannot be determined.

• 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: 10214946
• Report Number: 0009617544-2020-00111
• Device Sequence Number: 11581024
• Product Code: KWQ
• UDI-Device Identifier: 07613252152606
• UDI-Public: 07613252152606
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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: 66 YR