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

Catalog Number	48811230
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; a closing bar/wing on a 2 level plate did not move forward properly when the locking nut was final tightened.
Additional Manufacturer Narrative
Method: risk assessment; results: manufacturing files were not reviewed because no lot was provided and no product was returned.Conclusion: the plausible root cause of the reported is not determined.
Event or Problem Description
It was reported that; a closing bar/wing on a 2 level plate did not move forward properly when the locking nut was final tightened.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 30
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6490349
• Report Number: 0009617544-2017-00148
• Device Sequence Number: 10902002
• Product Code: KWQ
• UDI-Device Identifier: 07613252152194
• UDI-Public: (01)07613252152194
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/29/2017

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 Catalogue Number: 48811230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1