MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 40; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811240
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	09/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while locking the plate, the locking mechanism malfunctioned.It took about 10 minutes to take plate off and replace with a new one.No adverse consequences to the patient is reported.They surgery was completed successfully.This complaint will be reported as a malfunction.
Additional Manufacturer Narrative
Method: visual inspection, product history review, compliant history review, nc/capa history review, labelling review, risk assessment result: the sales rep reported event was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the potential causes of the reported event includes guide not properly attached to plate, guide/awl limits visibility, user tilts guide off axis affecting screw path, over-angulation of screwdriver which leads to unintended cantilever force, however a definite root cause cannot be determined at this time.
Event or Problem Description
It was reported that while locking the plate, the locking mechanism malfunctioned.It took about 10 minutes to take plate off and replace with a new one.No adverse consequences to the patient is reported.They surgery was completed successfully.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 40
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7987040
• Report Number: 0009617544-2018-00244
• Device Sequence Number: 11197324
• Product Code: KWQ
• UDI-Device Identifier: 07613252152231
• UDI-Public: 07613252152231
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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 Catalogue Number: 48811240
• Device Lot Number: 137621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR