MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR 11MM X 31MM X 0DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48393110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The cage tail broke during insertion.No response was received from the stryker representative regarding additional information.No adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
Method: risk assessment.Results: the event was confirmed via email correspondence with the sales representative.Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: too much impaction force on the inserter may damage the inserter and break the implant wings.Per email correspondence with the sales rep, the implant was impacted using a mallet with a normal force - no extra force was applied.The product was not returned for evaluation, therefore exact root cause cannot be determined conclusively.
Event or Problem Description
The cage tail broke during insertion.No response was received from the stryker representative regarding additional information.No adverse consequences or surgical delay were reported.

• Brand Name: NAVIGATOR 11MM X 31MM X 0DEG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7667802
• Report Number: 0009617544-2018-00167
• Device Sequence Number: 1370525
• Product Code: MAX
• UDI-Device Identifier: 07613252252627
• UDI-Public: (01)07613252252627
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K100865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2018

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: 48393110
• Device Catalogue Number: 48393110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 09/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1