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

Catalog Number 48230000S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : hospital discarded device.

Event Description

It was reported that approximately six months post-operatively a patient who had reported right side leg pain was revised to address the migration of a xia blocker.

Manufacturer Narrative

H6 coding has been updated to reflect investigation conclusion.

Event Description

It was reported that approximately six months post-operatively a patient who had reported right side leg pain was revised to address the migration of a xia blocker.

• Brand Name: XIA 3 TITANIUM BLOCKER
• 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: 18897391
• MDR Text Key: 337589179
• Report Number: 0009617544-2024-00026
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48230000S
• Device Lot Number: VE3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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