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

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Device is anticipated to be returned.

Event 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.

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9836752
• MDR Text Key: 184159025
• Report Number: 0009617544-2020-00040
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540539663
• UDI-Public: 04546540539663
• Combination Product (y/n): N
• PMA/PMN Number: K121342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 48132601
• Device Catalogue Number: 48132601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention