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

Model Number	48289999
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately 2.5 months post-operatively to address a migrated mantis redux blocker.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device remains implanted.
Event or Problem Description
It was reported that a patient was revised approximately 2.5 months post-operatively to address a migrated mantis redux blocker.

• 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: 16865147
• Report Number: 0009617544-2023-00021
• Device Sequence Number: 5421197
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48289999
• Device Catalogue Number: 48289999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian