MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48133480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem Description
During an operation to extend the original construct, it was noticed that a xia titanium 4.5 rod on the right side was broken, as well two xia titanium 4.5 polyaxial cross connectors at the t11-l1 and t3/4 levels.This report represents the rod.
Event or Problem Description
During an operation to extend the original construct, it was noticed that a xia titanium 4.5 rod on the right side was broken, as well two xia titanium 4.5 polyaxial cross connectors at the t11-l1 and t3/4 levels.This report represents the rod.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the xia 4.5 ifu: the surgeon must discuss all physical and psychological limitations inherent to the use of these devices with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion should be directed to the issues of premature weight bearing, activity levels, and the necessity for periodic medical follow-up.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.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) the surgeon must advise the patient that resultant forces can cause failure of the devices.The most likely root cause is excessive post op activity by the patient applying inordinate stress upon the implants, causing them to fracture.

• Brand Name: XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 480
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10228233
• Report Number: 0009617544-2020-00115
• Device Sequence Number: 16292121
• Product Code: NKB
• UDI-Device Identifier: 04546540449412
• UDI-Public: 04546540449412
• Combination Product (Y/N): N
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48133480
• Device Catalogue Number: 48133480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 49