MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY ONE LEVEL PLATE SIZE 14; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that the locking mechanism of an aviator one level plate detached post-operatively causing an aviator screw to migrate.The devices remain implanted, revision surgery has not been scheduled or performed at this time.This report captures the plate.
Event or Problem Description
It was reported that the locking mechanism of an aviator one level plate detached post-operatively causing an aviator screw to migrate.The devices remain implanted, revision surgery has not been scheduled or performed at this time.This report captures the plate.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.The reported issue of an aviator two level plate secure mechanism fracturing post operatively and one screw at c6 migrating was confirmed by x-rays provided.No abnormalities were identified on 2 months post-op x-rays.4 months post-op x-rays show one screw migrating out of the c6 vertebrae.A fragment of material of an unknown origin was identified above the plate.The complainant suggested that this is potentially fragment of a plate's locking mechanism however this cannot be confirmed.Since the device remains implanted and no additional information was provided, the cause of the reported event could not be determined.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• 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: 14255468
• Report Number: 0009617544-2022-00052
• Device Sequence Number: 4976122
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: 07613252152118
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 48811114
• Device Catalogue Number: 48811114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/25/2022
• 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: Male