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

Model Number	48233600
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a posterior orthodontic surgery was performed with scoliosis on (b)(6) 2018.On (b)(6) 2018, it was reported that the rod on the coccyx side is dislodged from the screw head.Loosening and detachment of the blocker could not be confirmed.Re-operation will be performed in the future.
Additional Manufacturer Narrative
Method: x-ray review, product history review, complaint history review, labelling review, risk assessment.Result: the customer reported event was confirmed via review of x- rays.The device has not been returned and it is unknown if it will be available after the revision surgery.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Review of the provided x rays indicate that the rod was not long enough to properly seat into the screw tulip.Not having sufficient rod overhang could cause the rod to slip out over time as the blocker may not get full contact with the rod to hold it down.Conclusion: the most likely root cause is insufficient rod length.
Event or Problem Description
It was reported that a posterior orthodontic surgery was performed with scoliosis on (b)(6) 2018.On (b)(6) 2018, it was reported that the rod on the coccyx side is dislodged from the screw head.Loosening and detachment of the blocker could not be confirmed.Re-operation will be performed in the future.
Additional Manufacturer Narrative
Correction: the complaint device was returned.Method: visual inspection, material analysis.Result: 4 blockers and a rod were returned after revision surgery was performed.No issue related to the reported event was found with the blockers.Upon visual inspection of the returned rod, it was confirmed that blocker on one end of the rod did not seat properly on the rod upon comparison to blocker on other end of the rod.Material analysis confirmed that there were no material or manufacturing defects in the rod.Review of the provided x rays indicate that the rod was not long enough to properly seat into the screw tulip.Not having sufficient rod overhang could cause the rod to slip out over time as the blocker may not get full contact with the rod to hold it down.This also explains the irregular blocker marks on the rod as noted in visual inspection.One returned blocker was found to have rod indentations on only 1 side of it, which is indicative of the rod not being long enough.Conclusion: the most likely root cause is insufficient rod length.
Event or Problem Description
It was reported that a posterior orthodontic surgery was performed with scoliosis on (b)(6) 2018.On (b)(6) 2018, it was reported that the rod on the coccyx side is dislodged from the screw head.Loosening and detachment of the blocker could not be confirmed.Re-operation will be performed in the future.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 600MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7558673
• Report Number: 0009617544-2018-00117
• Device Sequence Number: 10807221
• Product Code: NKB
• UDI-Device Identifier: 04546540560735
• UDI-Public: (01)04546540560735
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2018

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: 48233600
• Device Catalogue Number: 48233600
• Device Lot Number: XFF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 10/05/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 09/05/2018; 10/31/2018
• 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