MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY ONE LEVEL PLATE SIZE 14; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48811114
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 14mm plate locking mechanism fell off the track on locking and was protruding.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was confirmed to have a deformed spring bar.Manufacturing files were reviewed and no anomalies were found.Potential root causes include: excessive torsional force/cantilever force applied, screw not fully seated below spring-bar, screw inserted outside of design range, stripped screw head/screwdriver tip.
Event or Problem Description
It was reported that 14mm plate locking mechanism fell off the track on locking and was protruding.

• Brand Name: AVIATOR ASSY ONE LEVEL PLATE SIZE 14
• 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: 6501563
• Report Number: 0009617544-2017-00157
• Device Sequence Number: 1659438
• Product Code: KWQ
• UDI-Device Identifier: 07613252152118
• UDI-Public: (01)07613252152118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• 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): 07/25/2017

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: 48811114
• Device Catalogue Number: 48811114
• Device Lot Number: 164516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1