MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 18 X 20MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	48291820
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vlift cage set screw snapped off intra-operatively, leading to a 60 minute surgical delay.There were no reported adverse consequences to the patient and the surgery was completed with another cage.
Event or Problem Description
It was reported that a vlift cage set screw snapped off intra-operatively, leading to a 60-minute surgical delay.There were no reported adverse consequences to the patient and the surgery was completed with another cage.
Additional Manufacturer Narrative
Visual inspection revealed the screw head where the tip of the screwdriver sits was found to be damaged.Marks on screw indicate excessive force used during surgery.Device and complaint history records were reviewed for provided lot number.No relevant manufacturing issues or similar complaints were identified.Sales rep indicated that excessive force was not applied during surgery.Per surgical technique, to lock the outer distraction ring and the implant height, place the head of the screwdriver into the head of the locking screw.Rotate the screwdriver counterclockwise two full turns, which will cause the head of the locking screw to protrude out (back-out) of the implant and contact the outer distraction ring.The locking screw was not designed to provide any tactile feedback during the locking step.The locking screw should back-out of the implant freely with rotation of the screwdriver.The screwdriver was also designed to be low-profile to potentially eliminate unnecessary torque transmission to the locking screw.If the surgeon backs-out the locking screw past two full turns and reaches a point where the screw can no longer back-out, the surgeon should stop rotating the screwdriver.At this point, the implant height is locked and any further rotation of the locking screw may compromise its integrity.Some plausible root causes of the screw fractures are: excessive torque applied during implant expansion in-situ, user applies off-axis loading during expansion, and inserter not assembled correctly to implant.However the exact root cause could not be determined conclusively.

• Brand Name: VLIFT CAGE DIAM 18 X 20MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8786921
• Report Number: 0009617544-2019-00087
• Device Sequence Number: 1707836
• Product Code: MQP
• UDI-Device Identifier: 04546540557803
• UDI-Public: 04546540557803
• Combination Product (Y/N): N
• PMA/510(K) Number: K060506
• 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): 10/24/2019

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: 48291820
• Device Lot Number: 157290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1