MAUDE Adverse Event Report: STRYKER SPINE-US XIA ROD DIA. 6 X 480; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03802480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital kept the device.
Event or Problem Description
It was reported that a xia 2 rod fractured post-operatively.The patient was noted to have already achieved fusion.Revision surgery was performed to remove the fractured rod.
Additional Manufacturer Narrative
Visual, dimensional, material, and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From the xia ifu: the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that 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.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.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.As the rod was not returned, a definite root cause cannot be determined.However, based on the length of implantation (1 year) and the fact that the patient fused, fatigue fracture may have occurred.
Event or Problem Description
It was reported that a xia 2 rod fractured post-operatively.The patient was noted to have already achieved fusion.Revision surgery was performed to remove the fractured rod.

• Brand Name: XIA ROD DIA. 6 X 480
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9711543
• Report Number: 3005525032-2020-00017
• Device Sequence Number: 3171758
• Product Code: NKB
• UDI-Device Identifier: 04546540147905
• UDI-Public: 04546540147905
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 03802480
• Device Catalogue Number: 03802480
• Device Lot Number: 95L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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
• Patient Age: 29 YR