MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS REDUX BLOCKER; IMPLANT-BLOCKER

Catalog Number 48289999

Device Problems Loose or Intermittent Connection (1371); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 07/05/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, es2 surgery was performed and l4-5 was fixed.Two weeks after surgery, the left side blockers came loose and rod moved.Revision surgery which blockers are replaced is planned at a later date.

Manufacturer Narrative

Results: an inspection could not be performed as the lot number and product were not received.Conclusion: the root cause cannot be determined based on the limited information provided.Product was not received.

Event Description

It was reported that on (b)(6) 2014, es2 surgery was performed and l4-5 was fixed.Two weeks after surgery, the left side blockers came loose and rod moved.Revision surgery which blockers are replaced is planned at a later date.

• Brand Name: MANTIS REDUX BLOCKER
• Type of Device: IMPLANT-BLOCKER
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): CERSYS INC; 3451 commerce parkway; miramar FL 33025 336
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4088433
• MDR Text Key: 4762167
• Report Number: 0009617544-2014-00401
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48289999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• 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
• Patient Outcome(s): Required Intervention