MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF DRILLING SCREW 4X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48824016
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The screw was returned and inspected.Discoloration and deformation are observed on the screws head; most likely due to implantation and explantation.Per surgical technique: use of the screw hole preparation instruments including the fixed or variable drill guides, all-in-one drill guides or punch awl with sleeves is required to place screws in the proper trajectory, help prevent damage to implants, difficulty locking the blocker, or locking mechanism malfunction.If self-drilling screws are used, use either the punch awl with a sleeve or a drill bit and drill guide to center and direct the pathway of the screw.Note: using the punch awl is strongly recommended when self-drilling screws are used, as it helps to provide an optimal screw trajectory.Do not cantilever the guide during removal from plate as it can damage locking mechanism.When screws are fully inserted within the allowed range of angulation, the spring bar can then expand over the screw head.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.Patients who smoke have been shown to have an increased incidence of non-unions.Such patients must be advised of this fact and warned of the potential consequences.Stryker spine devices are indicated for treatment of fracture or stabilization of a surgical site during the normal bone consolidation process.As no x-rays or additional information was received, the root cause of the reported event cannot be determined.Potential root causes could be: improper plate sizing or contouring.Excessive post-op activity by patient (not recommended by surgeon).Patient does not follow surgeon instructions.Patient over exerts.Previous revision surgeries / acdf procedures intraoperative dissections (could have cause a tear from a previous surgery to sensitive anatomy/soft tissue).
Event or Problem Description
It was reported that an aviator assy 3-level plate securing mechanism fractured and 3 aviator screws migrated post-operatively three weeks after implantation.The patient has undergone revision surgery and the screws have been explanted.The plate remains implanted.This report will capture the third of three screws.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10186781
• Report Number: 0009617544-2020-00100
• Device Sequence Number: 3016983
• Product Code: KWQ
• UDI-Device Identifier: 07613252152613
• UDI-Public: 07613252152613
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 06/23/2020

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: 48824016
• Device Catalogue Number: 48824016
• Device Lot Number: 385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 06/23/2020
• 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: 51 YR
• Patient Weight: 77