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

Model Number	551-7310A
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Disc Impingement (2655)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history was reviewed and showed the device was manufactured according to the specification.
Event or Problem 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
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7297565
• Report Number: 1722511-2018-00003
• Device Sequence Number: 11357611
• Product Code: MAX
• UDI-Device Identifier: 00822409020966
• UDI-Public: (01)00822409020966(17)220510(10)A178111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: Health Professional
• Device Expiration Date: 05/10/2022
• Device Model Number: 551-7310A
• Device Lot Number: A178111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1