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

Catalog Number	48289999
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a mantis redux blocker at l2 migrated post-operatively.No adverse consequences were reported.The migrated blocker was observed in an x-ray taken for a planned revision surgery to remove all implants as the patient was reported to have achieved good bone union.The blocker was explanted.
Event or Problem Description
A company representative reported that a mantis redux blocker at l2 migrated post-operatively.No adverse consequences were reported.The migrated blocker was observed in an x-ray taken for a planned revision surgery to remove all implants as the patient was reported to have achieved good bone union.The blocker was explanted.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.Additional data: d4, d9, h3, h4.

• Brand Name: MANTIS REDUX BLOCKER
• Common Device Name: 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: 19799126
• Report Number: 0009617544-2024-00112
• Device Sequence Number: 20930104
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: (01)04546540671431(11)211214(10)C39
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48289999
• Device Lot Number: C39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian