MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 18 X 32MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	48291832
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vlift cage securing mechanism fractured intra-operatively.While threading the set screw further into the cage to allow for height adjustment, the 'set screw tip broke off'.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by using a backup cage.
Additional Manufacturer Narrative
Visual inspection: the screw head where a 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 and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: 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.The exact root cause could not be determined conclusively but it is possible that the surgical technician applied excessive force while advancing the screw in clockwise motion.
Event or Problem Description
It was reported that a vlift cage securing mechanism fractured intra-operatively.While threading the set screw further into the cage to allow for height adjustment, the 'set screw tip broke off'.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by using a backup cage.

• Brand Name: VLIFT CAGE DIAM 18 X 32MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10125729
• Report Number: 0009617544-2020-00081
• Device Sequence Number: 2464249
• Product Code: MQP
• UDI-Device Identifier: 04546540557827
• UDI-Public: 04546540557827
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 08/27/2020

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: 48291832
• Device Catalogue Number: 48291832
• Device Lot Number: 164354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1