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	02/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rod broke post surgery.Revision surgery was performed.
Additional Manufacturer Narrative
Method: risk assessment; x-rays.Results: visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the rods were found fractured about 9 months after the original surgery.Fusion did not occur.The x ray 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.This, along with the curvature of the spine, could cause a bending moment.Over time this could cause the rods to fracture due to the stress and strain of the construct.However since the device was not returned for evaluation the definite root cause cannot be determined.
Event or Problem Description
It was reported that the rod broke post surgery.Revision surgery was performed.

• 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: 7318825
• Report Number: 0009617544-2018-00061
• Device Sequence Number: 19276279
• Product Code: OSH
• UDI-Device Identifier: 04546540539663
• UDI-Public: (01)04546540539663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 02/12/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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