MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 12; INAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48811112
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; 12 mm plate spring bar was deformed while surgeon was implanting.Back up 12 mm plate was used.
Additional Manufacturer Narrative
The aviator plate deformation was confirmed via visual inspection.The plate was confirmed to have a spring bar deformed.No relevant manufacturing issues were identified as all units met stryker specifications.The plausible root cause of the event was determined to be using a freehand technique during holes preparation.It is recommended to use variable or fixed drill guide to ensure the proper angulation of the screw so as not to damage the spring bar.
Event or Problem Description
It was reported that; 12 mm plate spring bar was deformed while surgeon was implanting.Back up 12 mm plate was used.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 12
• Common Device Name: INAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6681584
• Report Number: 0009617544-2017-00274
• Device Sequence Number: 121272
• Product Code: KWQ
• UDI-Device Identifier: 07613252152101
• UDI-Public: (01)07613252152101
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/29/2017

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: 48811112
• Device Catalogue Number: 48811112
• Device Lot Number: 170932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1