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

Model Number	551-7308A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to insert an intervertebral cage, the frame of the cage twisted and was damaged and broken.A new cage was opened and the same thing occurred.No additional adverse consequences have been reported.This report is being filed due to the possibility that some small piece(s) may have remained in the body.

• Brand Name: VUSION OS
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 10547465
• Report Number: 1722511-2020-00019
• Device Sequence Number: 3074137
• Product Code: MAX
• UDI-Device Identifier: 00822409020942
• UDI-Public: (01)00822409020942(17)231029(10)A203994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

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: 10/29/2023
• Device Model Number: 551-7308A
• Device Lot Number: A203994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1