MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	03828640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that a xia monoaxial screw was observed to have fractured approximately nine years post-operatively.The patient reported experiencing a sore waist and was hospitalized for observation and "conservative treatment".Revision surgery has not taken place nor been scheduled.
Additional Manufacturer Narrative
Corrected data: b5.
Event or Problem Description
A customer reported that a xia monoaxial screw was observed to have fractured approximately five years post-operatively.The patient reported experiencing a sore waist and was hospitalized for observation and "conservative treatment".Revision surgery has not taken place nor been scheduled.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 40MM
• 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23245007
• Report Number: 0009617544-2025-00084
• Device Sequence Number: 10419400
• Product Code: NKB
• UDI-Device Identifier: 07613154407637
• UDI-Public: (01)07613154407637(11)150323(10)152879
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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: 03828640
• Device Lot Number: 152879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 11/25/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/17/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2015
• 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: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG