MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 18 X 25MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	48291825
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during insertion of a vlift cage, the cage and the vlift extension began "dismantling" intra-operatively.Surgery was successfully completed with non-stryker devices and a two hour delay.This report will capture the cage.
Additional Manufacturer Narrative
Visual analysis: the end caps were found attached to the cage on both sides.They were disassembled with the endcap remover.Deformation was noticed on the prongs of the extension.No deformation/damage was noticed on the cage.Functional analysis: the cage was able to screw out to expand and screw in to collapse without any issues.The extension was aligned with the cage body and the press fit was confirmed as indicated in the surgical technique.The event is related to in vivo performance and in vivo functionality cannot be duplicated.Dimensional analysis was performed on the cage and the extension with a caliper.The inner diameter confirms with the drawing.There is a difference in the outer diameter of 0.01 (mm) however this does not indicate nonconformity.The extension was impacted in vivo therefore dimensions were altered.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: extension is press fit onto both ends of the vlift implant to build a longer implant construct when necessary.A mallet may be used to assemble the extension.The vlift implant contains a pre-assembled locking screw, which is locked with the screwdriver to secure the implant height after distraction.The screwdriver is placed into the head of the locking screw in situ, which is then turned (backed-out) two full turns counterclockwise to lock the distraction mechanism in place.When removing the angled end caps, insert the shortest end of the end cap into the end cap remover.Extension can be removed by hand.The implants were inspected prior to the surgery and no visible damage was identified.The implants were new prior to surgery and never used; the user was experienced with the system.The cage functioned as expected outside patient's body, however in vivo functionality cannot be duplicated.The cause of the reported event cannot be determined conclusively.Per inspection, returned implants confirm to design specification.Factors that may have contributed to difficult assembly: cage damaged during impaction, patient's anatomy, tight disc space, poor visualization.
Event or Problem Description
It was reported that during insertion of a vlift cage, the cage and the vlift extension began "dismantling" intra-operatively.Surgery was successfully completed with non-stryker devices and a two hour delay.This report will capture the cage.

• Brand Name: VLIFT CAGE DIAM 18 X 25MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10950611
• Report Number: 0009617544-2020-00206
• Device Sequence Number: 19509546
• Product Code: MQP
• UDI-Device Identifier: 04546540557810
• UDI-Public: 04546540557810
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 48291825
• Device Catalogue Number: 48291825
• Device Lot Number: 198856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 03/24/2021
• 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: Other
• Patient Age: 39 YR