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

Model Number	482365550
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem 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
• Common Device Name: 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
• Report Number: 0009617544-2022-00110
• Device Sequence Number: 6601159
• Product Code: NKB
• UDI-Device Identifier: 04546540602039
• UDI-Public: 04546540602039
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female