MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR 8MM X 26MM X 0DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48392080
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; first implant was used with bayonetted inserter and came dislodged when inserting.Rail on implant appeared malformed and was not reattached.Surgeon then attempted to place different implant on straight inserter and experienced the same outcome.Per surgeon, no patient adverse event resulted from implants being dislodged.Surgeon did not attempt to place a third implant.
Additional Manufacturer Narrative
Method: visual inspection; design history review; complaint history review; risk assesment.Result: the reported event was confirmed via functional analysis of the returned implant.The "rail" of the implant was found to be deformed upon visual inspection.No relevant manufacturing issues found upon manufacturing history review.Conclusion: it is likely that the implants may have damaged during the impaction which damaged the rail of both of the implants and due to which the implants dislodged and were unable to reattach during the insertion.
Event or Problem Description
It was reported that; first implant was used with bayonetted inserter and came dislodged when inserting.Rail on implant appeared malformed and was not reattached.Surgeon then attempted to place different implant on straight inserter and experienced the same outcome.Per surgeon, no patient adverse event resulted from implants being dislodged.Surgeon did not attempt to place a third implant.

• Brand Name: NAVIGATOR 8MM X 26MM X 0DEG
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5732126
• Report Number: 0009617544-2016-00240
• Device Sequence Number: 1048280
• Product Code: MAX
• UDI-Device Identifier: 07613252252207
• UDI-Public: (01)07613252252207
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K100865
• 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): 05/25/2016

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: 48392080
• Device Lot Number: 156990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2016
• Supplement Report FDA Received Date: 08/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1