MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48232600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that primary surgery was performed on (b)(6) 2013 and devices were implanted from t4 to iliac.Post operatively it was discovered that the rod broke at the head side of t12.Revision surgery took place on (b)(6) 2018.The screw was deployed from t7 to t11 and the rod was cut at the caudal side of the of the t12 and the screw of the t12 was removed.Finally, it was extended with connector and the operation was finished.
Additional Manufacturer Narrative
Method: visual inspection, material analysis, device history review, complaint history review, risk assessment.Result: the reported event was confirmed via visual inspection.The rod was confirmed to be fractured into 2 pieces.The device was sent for material analysis.The rod was found to have fractured in fatigue at a contact point with the polyaxial screw.The elemental constituent was consistent with the material listed on the print.No material or manufacturing defects were found.Conclusion: the device was implanted for almost 5 years, the most likely root cause is fatigue fracture of the rod due to length of implantation due to non fusion.The surgical technique states that " 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.Fatigue fracture of spinal fixation devices, including screws and rods, has occurred.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.".
Event or Problem Description
It was reported that primary surgery was performed on (b)(6) 2013 and devices were implanted from t4 to iliac.Post operatively it was discovered that the rod broke at the head side of t12.Revision surgery took place on (b)(6) 2018.The screw was deployed from t7 to t11 and the rod was cut at the caudal side of the of the t12 and the screw of the t12 was removed.Finally, it was extended with connector and the operation was finished.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 600MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7493403
• Report Number: 0009617544-2018-00106
• Device Sequence Number: 239159
• Product Code: NKB
• UDI-Device Identifier: 04546540560582
• UDI-Public: (01)04546540560582
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: Health Professional
• Device Model Number: 48232600
• Device Catalogue Number: 48232600
• Device Lot Number: BLK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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