MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 26; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48811226
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	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking spring of the plate broke intra-op.The surgery was completed successfully with back-up plate.A surgical delay of 5-10 min was reported.No adverse consequences to the patient was reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via visual inspection.It was reported that the deformed locking mechanism was noticed during final tightening of the locking mechanism and that the final tightening (solid) screwdriver was used as recommended by the surgical technique.Conclusion: it appears that the surgical technique was followed, so the potential causes may be: excessive torsional force/cantilever force applied.Screw not fully seated below spring-bar.Screw inserted outside of design range.Freehand method used to prepare/insert screws.Stripped screw head/screwdriver tip.However a definite root cause cannot be determined at this time.
Event or Problem Description
It was reported that the locking spring of the plate broke intra-op.The surgery was completed successfully with back-up plate.A surgical delay of 5-10 min was reported.No adverse consequences to the patient was reported.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 26
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8207848
• Report Number: 0009617544-2019-00001
• Device Sequence Number: 2745698
• Product Code: KWQ
• UDI-Device Identifier: 07613252152170
• UDI-Public: 07613252152170
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 48811226
• Device Lot Number: 184684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR