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

Model Number	48291832
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text : status and location of the device are currently unknown.
Event or Problem Description
It was reported that a vlift cage in l3 migrated post-operatively.Revision surgery was performed during which a new cage was placed.
Additional 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 or Problem 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
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9466705
• Report Number: 0009617544-2019-00137
• Device Sequence Number: 16841650
• Product Code: MQP
• UDI-Device Identifier: 04546540557827
• UDI-Public: 04546540557827
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 48291832
• Device Catalogue Number: 48291832
• Device Lot Number: 191685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR