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 Codes	Dysphagia/ Odynophagia (1815); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while explanting an aviator plate during a revision acdf procedure approximately 3 years after index surgery, the locking mechanism of the plate was observed to be broken.Additional information received from the surgeon also states that one aviator variable screw had migrated at c6, the level where the locking mechanism of the plate fractured.The patient was revised to remove the construct.This record captures the migrated aviator variable screw.
Additional Manufacturer Narrative
The aviator plate and four aviator screws were returned for evaluation.No visual anomalies were identified on the screws.The screw placed in the lower level on the left where the locking mechanism is fractured migrated out of the plate.The remaining three screws are concomitant.It cannot be determined which screw migrated.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Communication with the surgeon suggests that there were no complications in the index surgery and all screws were locked.The surgeon does not recall if the plate was bent to accommodate patient's anatomy nor other details regarding the initial surgery.X-rays were taken 6 weeks post-operatively, and no issues were identified.Further follow ups indicated that the patient had fused.Approximately 3 years after the initial surgery, the patient reported difficulty with swallowing.Upon follow up x-rays, it was noticed that one of the screws migrated ¾ out of the plate.The swallow study was done and the screw was almost parallel to the spine, and it was is moving with swallowing.Endoscopic examination of the esophagus was done and revealed no damage.Revision surgery was performed to explant all four screws and the plate.The hardware was implanted for approximately three years and the patient fused.Per the surgical technique, stryker spine 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.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.Potential root causes of screw migration 3 years after the surgery: excessive post-op activity by patient (not recommended by surgeon), patient does not follow surgeon instructions, patient over exerts.As the hardware was implanted for three years, and the patient fused, the stryker device accomplished it's intended use.However, a specific root cause cannot be determined conclusively.
Event or Problem Description
It was reported that while explanting an aviator plate during a revision acdf procedure, approximately 3 years after index surgery, the locking mechanism of the plate was observed to be broken.Additional information received from the surgeon also states that one aviator variable screw had migrated at c6, the level where the locking mechanism of the plate fractured.The patient was revised to remove the construct.This record captures the migrated aviator variable screw.

• 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
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12684033
• Report Number: 0009617544-2021-00208
• Device Sequence Number: 4985683
• Product Code: KWQ
• UDI-Device Identifier: 07613252152606
• UDI-Public: 07613252152606
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: V3K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown