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	Injury (2348)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Doctor has kept the device.
Event or Problem Description
Physician reported that interbody fusion was done from t3 to l2 for spinal scoliosis.The left xia titanium 4.5 vitalium rod 4.5 x 600 mm fractured post- operatively.Revision surgery occurred and both the left and right rods were replaced.This record captures the left side rod fracture.
Additional Manufacturer Narrative
Corrected data: d.7.Date of explant updated from (b)(6) 2019 to (b)(6) 2019.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: the patient must be warned that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) he should be warned that resultant forces can cause failure of the device.Patients who smoke have been shown to have an increased incidence of non-unions.Such patients should be advised of this fact and warned of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.Root cause of the reported event could not be determined conclusively as the product was not returned.Possible root causes include: excessive patient post-op activities beyond surgeon recommendation.Patient non-fusion.Surgeon applying too much torque to tighten the blockers.Poor fixation construct.
Event or Problem Description
Physician reported that interbody fusion was done from t3 to l2 for spinal scoliosis.The left xia titanium 4.5 vitalium rod 4.5 x 600 mm fractured post- operatively.Revision surgery occurred and both the left and right rods were replaced.This record captures the left side rod fracture.

• 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
• MDR Report Key: 9521041
• Report Number: 0009617544-2019-00146
• Device Sequence Number: 3245080
• Product Code: NKB
• UDI-Device Identifier: 04546540539663
• UDI-Public: 04546540539663
• Combination Product (Y/N): N
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention