MAUDE Adverse Event Report: AURORA SPINE INC VOX LLIF INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Model Number 107-04518-0812

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

It is speculated that the surgeon did not distract the disc space enough to accommodate the size implant that was being inserted.Due to the small opening, it is likely that the cage could not easily be inserted and thus, an excessive amount of force was used to impact the cage into the disc space.The cage cracked and broke into multiple pieces after several impactions.At the surgeon's discretion, he determined leaving the cage implanted was the best course of action.The patient will continue to be monitored by her healthcare practitioners with follow ups and any adverse changes will be reported by the hospital to aurora.

Event Description

Vox cage (p/n: (b)(4)) broke upon insertion.At the surgeon's discretion, he decided to leave the remainder of the cage implanted and will continue to monitor the patient with follow ups.There have been no further complaints from the patient according to the hospital.

• Brand Name: VOX LLIF INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): AURORA SPINE INC; 1930 palomar point way; suite 103; carlsbad CA 92008
• Manufacturer (Section G): AURORA SPINE, INC.; 1930 palomar point way; suite 103; carlsbad CA 92008
• Manufacturer Contact: laura mullens ; 1930 palomar point way; suite 103; carlsbad, CA 92008 ; 7605292468
• MDR Report Key: 8738177
• MDR Text Key: 149350948
• Report Number: 3010326971-2019-00002
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 107-04518-0812
• Device Catalogue Number: 107-04518-0812
• Device Lot Number: 1252-3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 73