MAUDE Adverse Event Report: ORTHO DEVELOPMENT VUSION; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 551-7310A

Device Problem Osseointegration Problem (3003)

Patient Problem Disc Impingement (2655)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device history was reviewed and showed the device was manufactured according to the specification.

Event Description

The patient underwent tlif on (b)(6) 2017.Post operatively, it was discovered that the device had "back-out." a revision surgery was performed on (b)(6) 2018 and the device was removed.

• Brand Name: VUSION
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020
• MDR Report Key: 7297565
• MDR Text Key: 101250729
• Report Number: 1722511-2018-00003
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00822409020966
• UDI-Public: (01)00822409020966(17)220510(10)A178111
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2022
• Device Model Number: 551-7310A
• Device Lot Number: A178111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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