MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48230000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device location unknown.
Event or Problem Description
It was reported that 2 months after implantation, a right-side xia 3 blocker and a left-side xia 3 blocker migrated, and a left-side xia 3 polyaxial screw fractured.The patient was revised approximately 1 year later to address the migrated blockers and fractured screw.The patient experienced mildly increasing low back and pelvic pain.This report is for the right-side xia 3 blocker.

• Brand Name: XIA 3 TITANIUM 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: 16907205
• Report Number: 0009617544-2023-00022
• Device Sequence Number: 6847429
• Product Code: NKB
• UDI-Device Identifier: 04546540560193
• UDI-Public: 04546540560193
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: 48230000
• Device Catalogue Number: 48230000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 23 YR
• Patient Sex: Female