MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482316550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was revised to address a fractured xia polyaxial screw at right s1.The patient reported pain and ct scan identified the fractured screw.The fractured shaft was unable to be removed during revision and remains in the patient; the replacement screw was placed in the bone slightly lateral to the fractured shaft.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
A patient was revised to address a fractured xia polyaxial screw at right s1.The patient reported pain and ct scan identified the fractured screw.The fractured shaft was unable to be removed during revision and remains in the patient; the replacement screw was placed in the bone slightly lateral to the fractured shaft.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 50 MM
• 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: 19611070
• Report Number: 0009617544-2024-00103
• Device Sequence Number: 7167597
• Product Code: NKB
• UDI-Device Identifier: 04546540562258
• UDI-Public: (01)04546540562258(11)210610(17)260430(10)C12367
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 482316550
• Device Lot Number: C12367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• 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 Sex: Unknown