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

Catalog Number 48824016

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Feeding Problem (1850); Failure of Implant (1924); Discomfort (2330); Laceration(s) of Esophagus (2398)

Event Date 03/12/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to screw pull out post-operatively.

Event Description

A small piece of one screw that migrated, fractured during implant removal.All fractured pieces were retrieved.It was reported that the revision surgery was extended an additional hour due to the need to close the membrane surrounding the esophagus, caused by the broken plate.Additionally, the patient was required to have a feeding tube for a period of time; duration not reported.The revision surgery was completed successfully.There were no complications during the initial surgery.It was confirmed that the screws were positioned below the spring bar and the plate¿s locking mechanism was in the locked position.Screw holes were prepared with variable awl and were implanted at a difficult angle.Patient was reported to have good bone purchase, did not do any strenuous activity, and did not experience a fall.

Manufacturer Narrative

Visual inspection for 6 screws were returned.Four self- drilling 4x16mm screw and two self- drilling 4x16 screws.Two screws migrated post-op and the remaining screws are concomitant and were returned for archiving.Some scratches and discoloration was noticed on the screws most likely due to implantation/explanation.No other anomalies were noticed.Materials analysis was not performed as the event is not related to the material properties of the implants.Functional and dimensional analysis was not performed.Per what was reported, screw pathway was prepared as per the stg and it was confirmed that the screws were locked.The bone quality was good, no patient falls, and operative notes/medical history of the patient is not available.The root cause of the reported event cannot be determined conclusively.Potential root causes: improper plate sizing or contouring; excessive post-op activity by patient (not recommend ed by surgeon); previous revision surgeries / acdf procedures intra- operative dissections (could have cause a tear from a previous surgery to sensitive anatomy/soft tissue); patient does not follow surgeon instructions; patient over exerts.Root causes identified: user fails to use guidance instruments.Angulation of drill guide or awl; user fails to utilize the correct instruments in order to bend the plate; demonstration of finished goods and placing the implants back into the kit; insufficient spring thickness at lmc; interpretation of assembly drawing.The surgical technique states: ¿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.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 expectation s.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.".

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X16MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8501409
• MDR Text Key: 141561789
• Report Number: 0009617544-2019-00045
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152613
• UDI-Public: 07613252152613
• Combination Product (y/n): N
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48824016
• Device Lot Number: ZHL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR