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

Catalog Number	48811232
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was performing a c5-c7 acdf with the plate system.Surgeon was tightening a 4.35 self tapping screw at c7 when a spring bar at c5 popped up.Surgeon removed that plate and applied another to finish the case.No adverse consequences were reported.
Additional Manufacturer Narrative
The reported event was confirmed by the rep.Manufacturing files were not reviewed because no parts or lot # were provided.It was reported that the screws were self-drilled.The device 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." the probable root cause is not using the recommended instruments above.Device not returned.
Event or Problem Description
Surgeon was performing a c5-c7 acdf with the plate system.Surgeon was tightening a 4.35 self tapping screw at c7 when a spring bar at c5 popped up.Surgeon removed that plate and applied another to finish the case.No adverse consequences were reported.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 32
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7950394
• Report Number: 0009617544-2018-00238
• Device Sequence Number: 11178890
• Product Code: KWQ
• UDI-Device Identifier: 07613252152200
• UDI-Public: 07613252152200
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: No Information
• Device Catalogue Number: 48811232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1