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

Catalog Number 48236043

Device Problem Fracture (1260)

Patient Problems Hematoma (1884); Numbness (2415)

Event Date 11/09/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

Event 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
• Type of Device: 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
• MDR Text Key: 330114699
• Report Number: 0009617544-2023-00084
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540560872
• UDI-Public: 04546540560872
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142381
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 86 KG