MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS REDUX BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48289999

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  Injury  

Event Description

It was reported that a patient was revised to address four migrated mantis redux blockers approximately two months after implantation.This report captures the third of the four migrated blockers.

Event Description

It was reported that a patient was revised to address four migrated mantis redux blockers approximately two months after implantation.This report captures the third of the four migrated blockers.

Manufacturer Narrative

H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.

• Brand Name: MANTIS REDUX BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15481149
• MDR Text Key: 300565564
• Report Number: 0009617544-2022-00087
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48289999
• Device Catalogue Number: 48289999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2020
• 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