MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48232601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two xia 3 rods broke post-operatively.Revision surgery has occurred where the rods have been replaced.This report will capture the first of two rods.
Event or Problem Description
It was reported that two xia 3 rods broke post-operatively.Revision surgery has occurred where the rods have been replaced.This report will capture the first of two rods.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Device stg was reviewed: "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." no additional information regarding the products, procedure, or timeline of events was received.No x-rays were provided.According to the doctor, the patient's scoliosis worsened and this caused the rods to break.The most likely cause of the reported event was determined to be due to the progression of scoliosis, as reported by the medical professional over seeing the patient.H3 other text : status and location of the device is unknown.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 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-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13156831
• Report Number: 3005525032-2022-00001
• Device Sequence Number: 17533622
• Product Code: NKB
• UDI-Device Identifier: 04546540608642
• UDI-Public: 04546540608642
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 48232601
• Device Catalogue Number: 48232601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown