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

Catalog Number 48289999

Device Problem Migration (4003)

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

Event Date 01/27/2024

Event Type  Injury  

Manufacturer Narrative

Four potential lot numbers were provided for this device: er2, eya, fer, and gpz.

Event Description

A patient was revised to address a migrated mantis redux blocker at l3 approximately seven weeks after implantation.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

Event Description

A patient was revised to address a migrated mantis redux blocker at l3 approximately seven weeks after implantation.

• 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-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18785021
• MDR Text Key: 336285346
• Report Number: 3004024955-2024-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: ER2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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: 87 YR
• Patient Sex: Male