MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR 13MM X 31MM X 0DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48393130

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

It was reported that; cage broke.

Manufacturer Narrative

Risk assessment; the reported event of was confirmed via correspondence with the sales representative.It is reported that the product was disposed of and not lot# was provided.Therefore device evaluation, device history review, complaint history review could not be performed.The root cause of the reported event could not be determined without device evaluation.

Event Description

It was reported that; cage broke.

• Brand Name: NAVIGATOR 13MM X 31MM X 0DEG
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7147464
• MDR Text Key: 95934201
• Report Number: 0009617544-2017-00440
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48393130
• Device Lot Number: .
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1