MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482318590S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/04/2023

Event Type  Injury  

Manufacturer Narrative

Device retained by hospital.

Event Description

It was reported that a patient underwent revision surgery to address a xia polyaxial screw tulip disengagement on one side of the patient's spine and a xia polyaxial screw fracture on the other side.This report is for the xia polyaxial screw tulip disengagement.

Event Description

It was reported that a patient underwent revision surgery to address a xia polyaxial screw tulip disengagement on one side of the patient's spine and a xia polyaxial screw fracture on the other side.This report is for the xia polyaxial screw tulip disengagement.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM
• Type of Device: 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: 16953984
• MDR Text Key: 315477800
• Report Number: 0009617544-2023-00028
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482318590S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG