MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW BIASED ANGLE 7.5 X 80MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482387580

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/11/2022

Event Type  Injury  

Event Description

A company representative reported that a patient was revised three days post-operatively to address a tulip head disengagement from a xia 3 biased angle polyaxial screw.

Manufacturer Narrative

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

Event Description

A company representative reported that a patient was revised three days post-operatively to address a tulip head disengagement from a xia 3 biased angle polyaxial screw.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW BIASED ANGLE 7.5 X 80MM
• 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: 16062256
• MDR Text Key: 306277060
• Report Number: 3005525032-2022-00021
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613252020264
• UDI-Public: 07613252020264
• 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: 482387580
• Device Catalogue Number: 482387580
• Device Lot Number: A94903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2009
• 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: 15 YR
• Patient Sex: Female
• Patient Weight: 39 KG