MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 34; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811234
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was scheduled for 1 level acdf revision procedure due to degenerative disc disease.Right before the procedure, x-ray review revealed that locking ring of the plate from previous surgery has deformed.Therefore, the surgeon replaced the plate and screws during revision surgery and this resulted in 30 minutes surgical delay.
Additional Manufacturer Narrative
Securing mechanism deformation was confirmed via visual inspection.Functional inspection not performed because the event is unrelated to the function of the device dimensional inspection not performed because there is no indication the event was related to dimensions of the device.Material analysis was not performed as there is no indication the event was related to the material properties of the device.The screws backing out of the plate was the cause of the spring deformation.Complaint history review for similar events and device history records were reviewed and no relevant manufacturing issues nor similar events were identified.It was reported that during the primary surgery, the screws were below the spring bar and the plates locking mechanism was in the locked position.The patient¿s bone quality and post-operative activity are unknown.It is not known if the patient fused.The potential root causes include: poor surgical candidate or bone quality.Excessive post-op activity by patient (not recommended by surgeon).Patient does not follow surgeon instructions.Patient over exerts.
Event or Problem Description
It was reported that the patient was scheduled for 1 level acdf revision procedure due to degenerative disc disease.Right before the procedure, x-ray review revealed that locking ring of the plate from previous surgery has deformed.Therefore, the surgeon replaced the plate and screws during revision surgery and this resulted in 30 minutes surgical delay.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 34
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8518412
• Report Number: 0009617544-2019-00050
• Device Sequence Number: 14143023
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: 07613252152217
• 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): 06/20/2019

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: 48811234
• Device Lot Number: 16A900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1