MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT CAGE DIAM 18 X 25MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 48291825

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2018

Event Type  malfunction  

Event Description

It was reported that when installing the cage, head of the screw broke without applying any force and further blocking was impossible.Another cage was installed.No adverse consequences to the patient is reported.

Manufacturer Narrative

Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via email correspondence with the sales rep.The device was returned - and the reported screw fracture was confirmed.All broken fragments were retrieved.The surgical delay was around 30 min.Manufacturing history review revealed no relevant anomalies.Conclusion: based on the visual inspection on the returned units, the plausible root cause of the reported event are excessive torque applied during implant expansion in-situ, user applies off-axis loading during expansion, inserter not assembles correctly to implant.

Event Description

It was reported that when installing the cage, head of the screw broke without applying any force and further blocking was impossible.Another cage was installed.No adverse consequences to the patient is reported.

• Brand Name: VLIFT CAGE DIAM 18 X 25MM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7782792
• MDR Text Key: 117271147
• Report Number: 0009617544-2018-00191
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 04546540557810
• UDI-Public: 04546540557810
• Combination Product (y/n): N
• PMA/PMN Number: K060506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

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
• Device Operator: No Information
• Device Catalogue Number: 48291825
• Device Lot Number: 178773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 12/27/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1