MAUDE Adverse Event Report: STRYKER SPINE-FRANCE 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 Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a broken rod was noticed on a patient's x-ray upon a follow up visit.The hardware was revised during revision surgery.Parts of the rod were removed and new rods were connected to lower parts of the old rod.It was then secured into place with existing screws.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.2 rod fragments were returned as some of the old rod was left in patient and connected to new rods.Material analysis of the fragments found that the rod fractured in a unidirectional bending.The elemental composition matched the specified material on the drawing.No lot number was present on the fragments returned, so a manufacturing record review could not be performed.Conclusion: material analysis confirmed a fatigue fracture, most likely caused from the stresses and strains for from the implant's extended implantation.It was reported that the rod was implanted for a period of 8 years.Patient fusion also may have played a role as once the patient fuses, the implant completed its purpose.According to the ifu, "once implanted, the implants are subjected to stresses and strains.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidated.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.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.".
Event or Problem Description
It was reported that a broken rod was noticed on a patient's x-ray upon a follow up visit.The hardware was revised during revision surgery.Parts of the rod were removed and new rods were connected to lower parts of the old rod.It was then secured into place with existing screws.There are no reports of adverse health consequences to the patient.

• Brand Name: XIA II VITALIUM ROD 6.0 MM X 600 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7244820
• Report Number: 0009617544-2018-00033
• Device Sequence Number: 13661233
• Product Code: NKB
• UDI-Device Identifier: 04546540539656
• UDI-Public: (01)04546540539656
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: No Information
• Device Model Number: 03822601
• Device Catalogue Number: 03822601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 04/13/2018
• 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