MAUDE Adverse Event Report: SPINEART USA INC JULIET INSTRUMENTATION; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	JUL-IO 00 01-N
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Implant holder micro broke while md inserted and tried to place interbody device.

• Brand Name: JULIET INSTRUMENTATION
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SPINEART USA INC; 23332 mill creek dr. suite 150; laguna hills CA 92653
• MDR Report Key: 9847806
• Report Number: 9847806
• Device Sequence Number: 19426427
• Product Code: MAX
• UDI-Device Identifier: 07640139349972
• UDI-Public: (01)07640139349972
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/13/2020
• Report Date (Section F): 02/18/2020

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 Model Number: JUL-IO 00 01-N
• Device Catalogue Number: JUL-IO 00 01-N
• Device Lot Number: 3-4939
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 64
• Date Report Sent to FDA: 02/18/2020