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	04/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vlift screwdriver inner shaft tip fractured intra-operatively.There were no adverse consequences to the patient, but an unspecified surgical delay was reported.
Additional Manufacturer Narrative
B.5 was corrected from 'it was reported that a vlift screwdriver inner shaft tip fractured intra-operatively.' to 'it was reported that a vlift inside shaft tip fractured intra-operatively.' d.1 was corrected from 'vlift screwdriver inner shaft' to 'vlift inside shaft'.D.3 was corrected from 'stryker spine-france' to 'stryker spine-us'.
Event or Problem Description
It was reported that a vlift inside shaft tip fractured intra-operatively.There were no adverse consequences to the patient, but an unspecified surgical delay was reported.
Additional Manufacturer Narrative
The investigation is still in process.We will communicate our findings regarding the cause of this event in our final report.
Event or Problem Description
It was reported that a vlift inside shaft tip fractured intra-operatively.There were no adverse consequences to the patient, but an unspecified surgical delay was reported.
Event or Problem Description
It was reported that a vlift inside shaft tip fractured intra-operatively.There were no adverse consequences to the patient, but an unspecified surgical delay was reported.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Because the device was not returned, an exact root cause could not be determined.Possible causes include: too much mechanical energy (axial, insertion, removal, compressive, torque, cantilever) device used past life of device previously damaged device used implant not rigidly attached to inserter.

• 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: 10083057
• Report Number: 0009617544-2020-00072
• Device Sequence Number: 2916282
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 05/20/2020; 06/17/2020; 08/30/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/17/2020; 07/16/2020; 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1