MAUDE Adverse Event Report: STRYKER SPINE-FRANCE NAVIGATOR 7MM X 31MM X 4DEG; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48396074

Device Problems Mechanical Problem (1384); Malposition of Device (2616)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2015

Event Type  Injury  

Event Description

It was reported that; during surgery, the surgeon inserted the cage using the inserter to l4-l5.When the surgeon made the cage rotate, the cage protruded anterior(left side) from the vertebral body.The surgeon has added the cut to lateral side for removing the cage.The surgeon removed the cage.

Manufacturer Narrative

Device history review; complaint history review; risk assessment no relevant manufacturing issues were identified as all released units met stryker specifications.The plausible root cause of this event can be: "incorrect positioning of an implant".

Event Description

It was reported that; during surgery, the surgeon inserted the cage using the inserter to l4-l5.When the surgeon made the cage rotate, the cage protruded anterior(left side) from the vertebral body.The surgeon has added the cut to lateral side for removing the cage.The surgeon removed the cage.

• Brand Name: NAVIGATOR 7MM X 31MM X 4DEG
• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5125121
• MDR Text Key: 27430653
• Report Number: 0009617544-2015-00432
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 48396074
• Device Lot Number: 14A864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR