MAUDE Adverse Event Report: STRYKER SPINE-US XIA II VITALIUM ROD 6.0 MM X 600 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03822601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two xia ii vitalium rods 'broke' post-operatively.Revision surgery was performed where the rods were replaced.This records represents the first of the two rods.
Additional Manufacturer Narrative
Visual inspection: a portion of the fractured rod was returned.Beach marks were present on the fracture surface which would be consistent with a fatigue fracture.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From the xia ifu: delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) should be revised or removed immediately before serious injury occurs.The devices were implanted for a period of 3 years.It is unknown if the patient fused during that time.Beach marks found on the rod are consistent with fatigue fracture.Additionally, the blockers on the connectors were found to be overtightened which could have added additional stresses to the construct which may have contributed to the device fractures.Other factors, such as patient activity may have also contributed to the event.
Event or Problem Description
It was reported that two xia ii vitalium rods 'broke' post-operatively.Revision surgery was performed where the rods were replaced.This records represents the first of the two rods.

• Brand Name: XIA II VITALIUM ROD 6.0 MM 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: 10175729
• Report Number: 0009617544-2020-00092
• Device Sequence Number: 16800682
• Product Code: NKB
• UDI-Device Identifier: 04546540539656
• UDI-Public: 04546540539656
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 03822601
• Device Catalogue Number: 03822601
• Device Lot Number: F4A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 07/25/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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: 80 YR