MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 18 X 25MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	48291825
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that a vlift cage securing mechanism disengaged post-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.There are no plans for revision surgery at this time as the clinical outcome is sufficient.
Event or Problem Description
It was reported that a vlift cage securing mechanism disengaged post-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.There are no plans for revision surgery at this time as the clinical outcome is sufficient.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From vlift surgical technique: patients involved in an occupation or activity that applies excessive loading upon the implant (e.G., substantial walking, running, lifting, or muscle strain) may be at increased risk for failure of the fusion and/or the device.Patients should be instructed in detail about the limitations of the implants, including, but not limited to, the impact of excessive loading through patient weight or activity, and be taught to govern their activities accordingly.The procedure will not restore function to the level expected with a normal, healthy spine, and the patient should not have unrealistic functional expectations.Root cause of the reported event cannot be determined since the device was not returned.Potential causes include: improper locking of distraction mechanism during initial surgery, locking mechanism loosening, incorrect device assembly, instantaneous loading/fatigue, and/or patient activity.

• Brand Name: VLIFT CAGE DIAM 18 X 25MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9700728
• Report Number: 0009617544-2020-00020
• Device Sequence Number: 16596736
• Product Code: MQP
• UDI-Device Identifier: 04546540557810
• UDI-Public: 04546540557810
• Combination Product (Y/N): N
• PMA/510(K) Number: K060506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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 Model Number: 48291825
• Device Catalogue Number: 48291825
• Device Lot Number: 190784
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1