MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 30; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 48811230

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Event Description

It was reported by surgeon that aviator two level plate was 'unable to fully seat screw past spring bar mechanism or able to final lock secondary mechanism'.Plate was removed and a new plate was used to complete the procedure with 5 minute delay.No adverse consequences or medical intervention were reported.

Manufacturer Narrative

Upon visual inspection of the device, it was confirmed that one spring bar was deformed.The wings were lifted away from the main body.The ring around deformed spring bar is deformed as well indicating that excessive force was applied while trying to lock the screw.Slight discoloration was identified on the plate's body.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: the aviator plate has been designed with a slight sagittal and axial bend for matching of a patient¿s anatomy.If additional sagittal plate contouring is necessary, the plate bender may be used.The plate bender has two sides: (+) which will increase lordosis and (-) which will decrease lordosis.Position the plate face-up to increase lordosis or face-down to decrease lordosis.Insert the plate on the appropriate side of the plate bender so that the axial curve of the plate matches the curve in the slot.The plate should fit between the two notches on either side of the slot, so that bending only occurs in the graft windows.Bend plates incrementally to help match patient anatomy.Note: do not bend plates over the screw holes or the spring bar.The root cause of the reported event cannot be determined conclusively from the information provided.

Event Description

It was reported by surgeon that aviator two level plate was 'unable to fully seat screw past spring bar mechanism or able to final lock secondary mechanism'.Plate was removed and a new plate was used to complete the procedure with 5 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 30
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11667565
• MDR Text Key: 245502639
• Report Number: 0009617544-2021-00062
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07613252152194
• UDI-Public: 07613252152194
• Combination Product (y/n): N
• PMA/PMN Number: K142237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 48811230
• Device Catalogue Number: 48811230
• Device Lot Number: 200539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR