MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48232600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a xia 3 titanium rod fractured post-operatively.One 600mm xia 3 titanium rod was cut and implanted bilaterally.The patient had experienced external trauma (patient fell).Subsequently, when the patient came in for a post-operative examination, it was noted that the rod fractured bilaterally as well as the vertebral body.The patient was revised to remove the fractured rod and add additional fixation.This record captures the left side fracture of the xia titanium rod.
Additional Manufacturer Narrative
The provided x-ray confirms that both rods fractured- it was reported that the same rod was used bi-laterally.Fractures both occur superior to l5 screw head.Additionally, it was reported that the vertebral body was found to be fractured.There were no other device failures in the construct.The date of patient fall is unknown.Visual inspection was performed, and it was confirmed the returned left rod is fractured.A fracture fragment was also returned.The fracture surface of main rod is more smooth than the other end of the returned rod indicating fracture was most likely due to instantaneous.Additionally, no beach or wear marks can be seen on the fracture surface which further supports that this was an instantaneous fracture.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The xia 3 surgical technique guide was reviewed and the follow relevant information was identified: the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.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.The most likely cause of the reported event was determined to be due to patient fall outside of the hospital.The bi-lateral fracture of both rods in the same location indicates fractures were caused by an instantaneous stress.Lack of beach stress marks indicates fracture was due to instantaneous stress.Fracture of vertebral body indicates that the fall most likely generated enough force to fracture implants.The age of implantation likely contributed to the event as well.Implants cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.Devices were implanted for over 6 years at the time of event.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM
• 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: 13213040
• Report Number: 0009617544-2022-00001
• Device Sequence Number: 16520424
• Product Code: NKB
• UDI-Device Identifier: 04546540560582
• UDI-Public: 04546540560582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2022

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: 48232600
• Device Catalogue Number: 48232600
• Device Lot Number: GC4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2014
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 56 KG