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

Catalog Number	48291825
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 through visual inspection.All broken fragments were retrieved.The event lead to 30 minutes surgical delay.Manufacturing history review revealed no relevant anomalies.Result: 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 or Problem 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
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7782758
• Report Number: 0009617544-2018-00192
• Device Sequence Number: 1175407
• Product Code: MQP
• UDI-Device Identifier: 04546540557810
• UDI-Public: 04546540557810
• Combination Product (Y/N): N
• PMA/510(K) Number: K060506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Catalogue Number: 48291825
• Device Lot Number: 181196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1