MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48135103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was revised after two xia 4.5 titanium extended connectors fractured.This report captures the second of two connectors.
Event or Problem Description
A patient was revised after two xia 4.5 titanium extended connectors fractured.This report captures the second of two connectors.
Additional Manufacturer Narrative
Visual, dimensional, material, and functional analysis could not be performed as the device was not returned.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.Xia 4.5 surgical technique guide: adverse effects: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.Bending, disassembly or fracture of any or all implant components.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred.Additional warnings for pediatric patients: the safety and effectiveness of the xia 3 spinal system has not been established for use as part of a growing rod construct.This device is only intended to be used when definitive fusion is being performed at all instrumented levels.Growth rod constructs typically require repeated planned lengthening procedures until a determination is made that the patient is ready for a final fusion procedure.Growth rod patients are more susceptible to post-operative infections and wound-healing issues, as well as the potential for implant breakage requiring unplanned surgical procedures.The physician should discuss these and all other potential complications with the patient and the patient¿s guardian.The most likely root cause of the reported event was determined to be the duration of implantation; the device was active for over 2.5 years in a pediatric growth rod patient.H3 other text : device not returned.

• Brand Name: XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL
• 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: 13446892
• Report Number: 0009617544-2022-00011
• Device Sequence Number: 5462287
• Product Code: NKB
• UDI-Device Identifier: 04546540449580
• UDI-Public: 04546540449580
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 48135103
• Device Catalogue Number: 48135103
• Device Lot Number: 163518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2016
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 22 KG