MAUDE Adverse Event Report: STRYKER SPINE XIA 3; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482317580

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 08/12/2021

Event Type  malfunction  

Event Description

Patient had lumbar sacral fusion.X-rays taken the next day and discovered that sacral screws failed and underwent 2 level fusion with screws.

• Brand Name: XIA 3
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE; 2 pearl court; allendale NJ 07401
• MDR Report Key: 13847912
• MDR Text Key: 287618892
• Report Number: 13847912
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2022,09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 482317580
• Device Lot Number: B16147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male
• Patient Weight: 70 KG