MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR STRAIGHT INSERTER; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48393001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	02/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the surgeon inserted the cage using the inserter to l4-l5.The surgeon didn't notice cage loosening from the inserter at the same time.When the surgeon pushed the cage, the cage protruded anterior from the vertebral body.The surgeon did not remove the cage, and is monitoring for the patient now.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment; results: the device was not returned and lot# not provided, therefore device analysis, device history review and complaint history review could not be performed.Conclusion: the plausible root cause of this event cannot be determined since the device is not returned.
Event or Problem Description
It was reported that during the surgery, the surgeon inserted the cage using the inserter to l4-l5.The surgeon didn't notice cage loosening from the inserter at the same time.When the surgeon pushed the cage, the cage protruded anterior from the vertebral body.The surgeon did not remove the cage, and is monitoring for the patient now.

• Brand Name: NAVIGATOR STRAIGHT INSERTER
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5486222
• Report Number: 0009617544-2016-00101
• Device Sequence Number: 16434723
• Product Code: MAX
• UDI-Device Identifier: 07613327096194
• UDI-Public: 07613327096194
• Combination Product (Y/N): N
• 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): 02/12/2016

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: 48393001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 04/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1