MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482365550

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 10/06/2022

Event Type  Injury  

Event Description

It was reported that the tulip of a xia 3 uniplanar reduction screw became disengaged.The patient was implanted and still in hospital following the initial surgery when they reported experiencing pain.Imaging was performed and identified a disengaged tulip.Revision surgery was performed.

Manufacturer Narrative

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

Event Description

It was reported that the tulip of a xia 3 uniplanar reduction screw became disengaged.The patient was implanted and still in hospital following the initial surgery when they reported experiencing pain.Imaging was performed and identified a disengaged tulip.Revision surgery was performed.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 50MM
• 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: 15776725
• MDR Text Key: 303536541
• Report Number: 0009617544-2022-00110
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540602039
• UDI-Public: 04546540602039
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482365550
• Device Catalogue Number: 482365550
• Device Lot Number: 16E615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• 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; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female