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	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is anticipated to be returned.
Event or Problem Description
It was reported that a xia titanium 4.5 vitalium rod fractured post-operatively.Surgery was performed by glowing rod method, with the first extension scheduled for (b)(6) 2020.An examination of the patient revealed a broken rod before first extension could be performed.Revision was performed to replace the rod.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.However, x-rays were provided and confirmed that a rod on the right inferior side of the construct is fractured.The x-rays shows several levels of fixation at the top of the construct, and several levels of fixation at the bottom, and a section of non fixation in the middle.A review of device and complaint history could not be performed, as the lot number was not provided because the device was no returned.As the device was not returned for evaluation and additional information about the patient was not provided, a definite root cause cannot be determined.However likely root cause is the bending moment created by the construct and the existing curve of the spine caused the rod to fracture.
Event or Problem Description
It was reported that a xia titanium 4.5 vitallium rod fractured post-operatively.Surgery was performed by growing rod method, with the first extension scheduled for (b)(6) 2020.An examination of the patient revealed a broken rod before first extension could be performed.Revision was performed to replace the rod.

• 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: 9836752
• Report Number: 0009617544-2020-00040
• Device Sequence Number: 11530260
• 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 Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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