MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48236043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hematoma (1884); Numbness (2415)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised to address a fractured xia 3 titanium multiaxial crosslink the day after implantation.The patient reported, "numbness of the left leg," and the physician reported a hematoma had formed.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that a patient was revised to address a fractured xia 3 titanium multiaxial crosslink the day after implantation.The patient reported, "numbness of the left leg," and the physician reported a hematoma had formed.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM
• 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: 18296948
• Report Number: 0009617544-2023-00084
• Device Sequence Number: 7521090
• Product Code: NKB
• UDI-Device Identifier: 04546540560872
• UDI-Public: 04546540560872
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 03/13/2024

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 Catalogue Number: 48236043
• Device Lot Number: 233061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 86 KG