MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY THREE LEVEL PLATE SIZE 54; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811354
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been explanted but will not be returned.
Event or Problem Description
Physician reported that the locking wing of an aviator assy three level plate size 54 bent when the surgeon removed the plate intra- operatively.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: 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.Do not cantilever the guide during removal from plate as it can damage locking mechanism.When screws are fully inserted within the allowed range of angulation, the spring bar can then expand over the screw head.The root cause of the reported event is most likely due to overangulation of the screw as reported.
Event or Problem Description
Physician reported that the locking wing of an aviator assy three level plate size 54 bent when the surgeon removed the plate intra-operatively.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 54
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9312381
• Report Number: 0009617544-2019-00123
• Device Sequence Number: 19394663
• Product Code: KWQ
• UDI-Device Identifier: 07613252152316
• UDI-Public: 07613252152316
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 48811354
• Device Catalogue Number: 48811354
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1