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

Model Number 48291832

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Injury (2348)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Other text : status and location of the device are currently unknown.

Event Description

It was reported that a vlift cage in l3 migrated post-operatively.Revision surgery was performed during which a new cage was placed.

Manufacturer Narrative

Additional man.Narrative and correction- corrected data: h.3.Updated from 'status and location of the device are currently unknown' to 'device disposed' visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history was performed and no relevant manufacturing issues were identified as all units met stryker specifications.A review of complaint history records was performed, and no similar complaints were identified.Per surgical technique: once the expander is in proper alignment with the implant, the implant can be placed into the defect and distracted to the appropriate height.To distract the implant, simply rotate the outer cannulated shaft of the expander counterclockwise as indicated by the directional arrow, which is laser marked on the outside of the shaft.The counterclockwise rotation of the outer cannulated shaft will turn the outer distraction ring of the implant and result in distraction of the implant.Sales rep indicated that "the surgeon was not able to distract the vlift cage as much as he would have liked" during the initial surgery since the expander fractured.Most likely cause of reported event is insufficient distraction due to expander failure.Device disposed.

Event Description

It was reported that a vlift cage in l3 migrated post-operatively.Revision surgery was performed during which a new cage was placed.

• Brand Name: VLIFT CAGE DIAM 18 X 32MM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9466705
• MDR Text Key: 174707689
• Report Number: 0009617544-2019-00137
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 04546540557827
• UDI-Public: 04546540557827
• Combination Product (y/n): N
• PMA/PMN Number: K060506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48291832
• Device Catalogue Number: 48291832
• Device Lot Number: 191685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR