MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT INSIDE SHAFT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	48300210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vlift inside shaft fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, and functional analysis could not be performed because the device was not returned.A device history review could not be performed because the device associated with this event was not returned and the device lot number was not provided.A root cause could not be determined conclusively.Multiple attempts were made requesting return of the device as well as to obtain the additional information.Additional information was not made available and the device was not returned.
Event or Problem Description
It was reported that a vlift inside shaft fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.

• Brand Name: VLIFT INSIDE SHAFT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10255018
• Report Number: 0009617544-2020-00123
• Device Sequence Number: 11407296
• Product Code: LXH
• UDI-Device Identifier: 07613327267020
• UDI-Public: 07613327267020
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/18/2020

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: 48300210
• Device Catalogue Number: 48300210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1