MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. LUNA 3D; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number LUN3011

Device Problems Migration or Expulsion of Device (1395); Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 11/06/2018

Event Type  Injury  

Event Description

The patient had a surgical procedure on [date redacted], in which an l5-s1 fusion was performed and one of the implants was a luna 3d implant kit.Per the surgeon, the patient was readmitted for surgery due to cage failure.The vendor sent an email to the operating room (or) director that the luna implant and its associated locking mechanism had migrated and was irritating a nerve root.The operating room director was also notified that the device was defective by the vendor in person and requested the device be returned to him.The vendor was present during the procedure to remove the device.The plastic device and the retaining wire were removed.The patient did well post-operatively and was discharged two days later.

• Brand Name: LUNA 3D
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): BENVENUE MEDICAL, INC.; 4590 patrick henry drive; santa clara CA 95054
• MDR Report Key: 8150092
• MDR Text Key: 129888621
• Report Number: 8150092
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LUN3011
• Device Catalogue Number: LUN3011
• Device Lot Number: 17158009
• 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: 12/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22265 DA
• Patient Weight: 77