MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW BIASED ANGLE 7.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482387570

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  Injury  

Event Description

A patient was revised to address a xia polyaxial screw with a disengaged tulip approximately three weeks after implantation.

Event Description

A patient was revised to address a xia polyaxial screw with a disengaged tulip approximately three weeks after implantation.It was further reported that patient had additional hospital time.

Manufacturer Narrative

H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW BIASED ANGLE 7.5 X 70MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16139056
• MDR Text Key: 307103559
• Report Number: 3005525032-2023-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613252020257
• UDI-Public: 07613252020257
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/30/2023

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
• Device Operator: Health Professional
• Device Model Number: 482387570
• Device Catalogue Number: 482387570
• Device Lot Number: B40822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 39 KG