MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48233480
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product still remained implanted in the patient.
Event or Problem Description
It was reported that the two rods have dislodged post-op.The products still implanted in the patient.No other adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Method: x-ray image review, nc/capa history review, labelling review, risk assessment result : the reported event was confirmed via x rays.The device is still implanted in the patient therefore, device evaluation could not be performed.Lot # has not been provided , therefore, product history review could not be performed.X rays provided show the rods slipped out of the closed head screws.It was reported that patient was obese and anti torque not used.Post-op activity of the patient is unknown.Conclusion: as stated in the device ifu, the patient obesity, patient post op activity, and length of implantation could have contributed to the event.The extra weight on the implants could cause loosening over time.Additionally, not using anti torque when tightening down the blocker could have contributed as it could result in too much torque being applied to the set screw, possibly deforming it and reducing the surface area contacting the rod holding it in place.However, as the devices are still implanted, a definite root cause cannot be confirmed without evaluating the devices.Device is still implanted.
Event or Problem Description
It was reported that the two rods have dislodged post-op.The products still implanted in the patient.No other adverse consequence to the patient was reported.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM TI ALLOY L 480MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8114495
• Report Number: 0009617544-2018-00282
• Device Sequence Number: 19241876
• Product Code: NKB
• UDI-Device Identifier: 07613154918454
• UDI-Public: 07613154918454
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/21/2019

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: Health Professional
• Device Catalogue Number: 48233480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1