MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 32; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811232
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that the spring bar of an aviator two level plate fractured and a screw migrated post-operatively.The patient will be monitored and revision surgery has not been scheduled at this time.This report will capture the plate.
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that the spring bar of an aviator two level plate fractured and a screw migrated post-operatively.The patient will be monitored and revision surgery has not been scheduled at this time.This report will capture the plate.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device associated with this record remains implanted.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.It was reported that the spring bar of an aviator two level plate fractured and one screw at c4 migrated post-operatively which was confirmed by the x-ray provided.The patient will be monitored and revision surgery has not been scheduled at this time.Initial surgery was performed in mid november 2021.Patient had not fused.Construct spanned from c4-c6 and the angle of the plane was not difficult.Per email correspondence with sales rep, there were no complications during the initial surgery.Plate was not bent to fit the patient's anatomy, screw hole was prepared using drill bit, variable angle drill guide was used, no excess force was applied during the initial surgery, surgeon confirmed that the screws were below the spring bar before tightening blocker, surgeon did not face any difficulty while rotating the blocker and the gold tab on the blocker was confirmed to be aligned with the groove located between the two screws to confirm locking.Patient was not performing any heavy lifting and was wearing a neck collar.Patient did not experience any fall/ trauma after the initial surgery.The surgical technique was reviewed: ¿do not cantilever the guide during removal from the plate as it can damage the locking mechanism.When screws are fully inserted within the allowed range of angulation, the spring bar can then expand over the screw head.¿ since the device was not returned, an exact cause of the reported event could not be determined.Potential causes include screw not being below the spring bar before blocker tightening/ blocker not locked completely between the two screws leading to fracture of the locking ring and subsequent migration of screw.
Event or Problem Description
It was reported that the spring bar of an aviator two level plate fractured and a screw migrated post-operatively.The patient will be monitored and revision surgery has not been scheduled at this time.This report will capture the plate.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 32
• 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: 13549032
• Report Number: 0009617544-2022-00015
• Device Sequence Number: 14749222
• Product Code: KWQ
• UDI-Device Identifier: 07613252152200
• UDI-Public: 07613252152200
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48811232
• Device Catalogue Number: 48811232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown