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	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 2 level plate locking mechanism broke partially during insertion of the screw.The plate remains in the patient but the surgeon noticed that the locking mechanism seemed bent over the top of the screw.No adverse consequences to the patient were reported.
Event or Problem Description
It was reported that a 2 level plate locking mechanism broke partially during insertion of the screw.The plate remains in the patient but the surgeon noticed that the locking mechanism seemed bent over the top of the screw.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The customer reported event was confirmed by the stryker rep.The surgery was successfully completed and device remains implanted.Lot # was not provided, therefore, manufacturing records review could not be completed.Conclusion: the potential root causes includes: screw not fully seated below spring bar, incorrect screwdriver used to remove seated screw, poor visibility of spring-bar, spring-bar damaged prior to use,screw over angulated during insertion, blocker locked before visual confirmation of screw below spring bar, insufficient spring bar strength.

• 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: 7687747
• Report Number: 0009617544-2018-00175
• Device Sequence Number: 1329951
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: 07613252152187
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• 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): 10/22/2018

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: 48811228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1