MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48132601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two xia titanium 4.5 vitalium rods fractured approximately two years post-operatively.The patient has been revised.This record captures the second of the two fractured xia 4.5 rods.
Event or Problem Description
It was reported that two xia titanium 4.5 vitalium rods fractured approximately two years post-operatively.The patient has been revised.This record captures the second of the two fractured xia 4.5 rods.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed the rod is fractured.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It was initially reported that both rods fractured after a growth rod implantation.X-rays indicate that rods were implanted on (b)(6) 2021.Revision was performed on (b)(6) 2021.It was reported that the patient did not experience a fall and that the bone quality and patients activity level is unknown.The x-ray confirms rod fracture.Rod fracture occurred in the middle of the construct and towards the inferior end of the rod, where it meets the growth rod connector.Fracture location is similar on both sides of the construct.The xia surgical technique and xia growth rod conversion set ifu were reviewed: ¿the xia growth rod conversion set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.¿ ¿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.¿ due to the activity level of the patient being unknown, the root cause could not be definitively determined.Fracture location being the same bi-laterally indicates a traumatic event, fall, or other event may have potentially contributed to the event.However, this could not be confirmed.Additionally, there is a known inherent risk of rod fracture as ifu states: there is an increased risk of implant breakage in growth rod patients.

• Brand Name: XIA TITANIUM 4.5 VITALIUM ROD 4.5 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 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12868371
• Report Number: 0009617544-2021-00223
• Device Sequence Number: 6119333
• Product Code: NKB
• UDI-Device Identifier: 04546540539663
• UDI-Public: 04546540539663
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 48132601
• Device Catalogue Number: 48132601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 9 YR
• Patient Sex: Female