MAUDE Adverse Event Report: STRYKER SPINE-US XIA II VITALIUM ROD 6.0 MM X 600 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03822601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two xia ii vitalium rods fractured at l5/6 post-operatively.The patient was revised to replace the fractured rods and re-fix the construct.This record captures the first of the two xia ii vitalium rods.
Event or Problem Description
It was reported that two xia ii vitalium rods fractured at l5/6 post-operatively.The patient was revised to replace the fractured rods and re-fix the construct.This record captures the first of the two xia ii vitalium rods.
Additional Manufacturer Narrative
G1 has been corrected from "k2m, inc." to "stryker spine-france" a visual inspection was performed which confirmed rod fracture.X-ray confirms rod fractures occurred bi-laterally, just superior to the iliac screws.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.The xia ii surgical technique and device ifu were reviewed: ¿prior to adequate maturation of the fusion mass, implanted spinal instrumentation may need additional help to accommodate full load bearing.External support may be recommended by the physician from two to four months postoperatively or until x-rays or other procedures confirm adequate maturation of the fusion mass; external immobilization by bracing or casting be employed.Surgeons must instruct patients regarding appropriate and restricted activities during consolidation and maturation for the fusion mass in order to prevent placing excessive stress on the implants which may lead to fixation or implant failure and accompanying clinical problems.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred.¿ the most likely cause of the reported event was determined to be due to the age of implantation.Device was implanted for 1.5 years and it was reported that the patient healed.Device carried out its intended function.Location of bi-lateral fracture indicates a potential fall or external trauma, however, it was reported that the patient did not fall.

• Brand Name: XIA II VITALIUM ROD 6.0 MM X 600 MM
• 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 VA 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12704484
• Report Number: 0009617544-2021-00210
• Device Sequence Number: 11152719
• Product Code: NKB
• UDI-Device Identifier: 04546540539656
• UDI-Public: 04546540539656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: 03822601
• Device Catalogue Number: 03822601
• Device Lot Number: 2BJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2018
• 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
• Patient Age: 71 YR
• Patient Sex: Female