MAUDE Adverse Event Report: STRYKER SPINE STRYKER XIA PEDICLE SCREW SYSTEM FAVORED ANGLE POLY-AXIAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 12/09/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 patient underwent uncomplicated t3-pelvis fusion surgery with screws and rods from stryker spine and plastic surgery closure.On (b)(6) 2022, x-ray noted that her right pelvic screw was broken.Return to the operating room for revision of that screw on (b)(6) 2022.On (b)(6) 2022 xray showed that the left pelvic screw was broken in the same way as the right had been.Patient returned to operating room for revision of screw.

• Brand Name: STRYKER XIA PEDICLE SCREW SYSTEM FAVORED ANGLE POLY-AXIAL SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE
• MDR Report Key: 16272737
• MDR Text Key: 308582147
• Report Number: MW5114582
• Device Sequence Number: 2
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic