MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM RAD ROD DIAM 6MM L 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48238070
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient had original fusion on (b)(6) 2018.At the 6 week follow-up visit it was noted on xray that the rod slipped on the right side.Patient is asymptomatic and will be watched for now.
Additional Manufacturer Narrative
Method: x-rays, device history review, complaint history review, risk assessment; result: the reported event was confirmed via review of the x ray.The devices are still implanted, thus inspection cannot be performed.No lot number was provided, so manufacturing review could not be completed.Conclusion: overtightening of the blockers can deform the blocker and cause an insufficient connection with the rod, which can cause instability with the construct, and possibly lead the rod to slip out over time.The surgical technique advises the user to apply 12nm of torque as this is the optimal torque to hold the rod in place.It was reported by the sales representative that a surgeon potentially applied excessive force when tightening.As the blockers were not returned for evaluation, a definite root cause cannot be determined however based on the information provided, the most likely root cause is excessive torque applied to the blocker during final tightening.
Event or Problem Description
It was reported that a patient had original fusion on (b)(6) 2018.At the 6 week follow-up visit it was noted on xray that the rod slipped on the right side.Patient is asymptomatic and will be watched for now.
Additional Manufacturer Narrative
Method: x-rays, device history review, complaint history review, risk assessment; result: the reported event was confirmed via review of the x ray.The devices are still implanted, thus inspection cannot be performed.No lot number was provided, so manufacturing review could not be completed.Conclusion: overtightening of the blockers can deform the blocker and cause an insufficient connection with the rod, which can cause instability with the construct, and possibly lead the rod to slip out over time.The surgical technique advises the user to apply 12nm of torque as this is the optimal torque to hold the rod in place.It was reported by the sales representative that a surgeon potentially applied excessive force when tightening.As the blockers were not returned for evaluation, a definite root cause cannot be determined however based on the information provided, the most likely root cause is excessive torque applied to the blocker during final tightening.
Event or Problem Description
It was reported that a patient had original fusion on (b)(6) 2018.At the 6 week follow-up visit it was noted on xray that the rod slipped on the right side.Patient is asymptomatic and will be watched for now.

• Brand Name: XIA 3 TITANIUM RAD ROD DIAM 6MM L 70MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7598085
• Report Number: 3005525032-2018-00039
• Device Sequence Number: 1422017
• Product Code: NKB
• UDI-Device Identifier: 04546540560957
• UDI-Public: (01)04546540560957
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48238070
• Device Catalogue Number: 48238070
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1