MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY TWO LEVEL PLATE SIZE 28; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811228
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking bar on cervical plate bent and broke as screw was going in.The gold lock screw was orientated in the unlock position but the grey bar/wing did not spring out of the way.The surgeon removed the screw, leaving one screw at that level.There have been no adverse consequences to the patient.
Additional Manufacturer Narrative
It was confirmed by the sales representative that the plate's locking mechanism fractured and the plate was implanted with a 3-5 minute delay.Product inspection was not completed as no product was returned (implanted).Product history review was not completed as no lot was provided.Conclusion: the stryker rep reported that the holes were prepared freehand and not with the drill guides as recommended by the surgical technique guide, so the probable root cause is not using the drill guides as instructed.
Event or Problem Description
It was reported that the locking bar on cervical plate bent and broke as screw was going in.The gold lock screw was orientated in the unlock position but the grey bar/wing did not spring out of the way.The surgeon removed the screw, leaving one screw at that level.There have been no adverse consequences to the patient.

• 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: 7598012
• Report Number: 0009617544-2018-00139
• Device Sequence Number: 2067031
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: (01)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): 08/20/2018

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 Model Number: 48811228
• Device Catalogue Number: 48811228
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1