MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 28; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811228
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The bottom screws backed out and the locking mechanism was pushed out and snapped on the anterior cervical plate.The original surgery was approximately 2 years ago and the patient called the doctor complaining of neck pain.Revision surgery occurred.
Additional Manufacturer Narrative
Method: x-ray image review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed via received x-ray image.Device was not returned, therefore, an evaluation could not be performed.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the root cause of the reported event was determined to be backing out of bottom screws of the plate which resulted due to continuous load on the device for 2 years.
Event or Problem Description
The bottom screws backed out and the locking mechanism was pushed out and snapped on the anterior cervical plate.The original surgery was approximately 2 years ago and the patient called the doctor complaining of neck pain.Revision surgery occurred.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 28
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8109704
• Report Number: 0009617544-2018-00277
• Device Sequence Number: 13876425
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: 07613252152187
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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 Catalogue Number: 48811228
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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