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

Model Number DYN-IT 00 01-N

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

Large piece vendor instrument broke off during case, nothing left in patient.Did not delay or compromise case.The device broke in the wound.An intraoperative x-ray confirmed that all of the pieces were removed per the physician.

• Brand Name: JULIET INSTRUMENTATION
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SPINEART SA; 9130 irvine center dr; irvine CA 92618
• MDR Report Key: 8939647
• MDR Text Key: 155815120
• Report Number: 8939647
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/24/2019,07/09/2019

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
• Device Operator: Health Professional
• Device Model Number: DYN-IT 00 01-N
• Device Catalogue Number: DYN-IT 00 01-N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2019
• Date Report to Manufacturer: 08/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA