MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. LUNA 1.0 IMPLANT KIT, 8-DEGREE, 11MM; 11MM, 8-DEGREE, LUNA 1.0 LORDOTIC IMPLANT KIT

Model Number	LUN3011-08
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Post-operative pain and implant migration are listed in the device instructions for use (ifu) and in the procedural technique guide as known possible adverse effects associated with use of the system.Upon review of the available images from the original procedure, it appears that the device was in good position with the lock wire locked.The middle component is interlocked with the bottom component, but not fully interlocked with the top component.Prior to the revision surgery, pre-op images showed both middle and bottom components have moved outside of the disc space.The top, however, remains in its original location.In addition, it appears that the lock wire/lock screw system failed, allowing the implant to disassemble.Root cause of that failure could not be determined since the returned implant is in good condition with nothing out of the ordinary.On (b)(6) 2019, revision surgery was performed, and the surgeon was able to successfully remove the implant and replaced it with new hardware.Patient is confirmed to be doing well.A review of the lot history record confirmed no manufacturing nonconformities were issued to the reported lot that would have caused or contributed to this event.Based on review of the information provided, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
On (b)(6) 2019, benvenue received information of a luna that disassembled and migrated causing pain.Original date of surgery was (b)(6) 2018.Revision surgery was performed on (b)(6) 2019.

• Brand Name: LUNA 1.0 IMPLANT KIT, 8-DEGREE, 11MM
• Common Device Name: 11MM, 8-DEGREE, LUNA 1.0 LORDOTIC IMPLANT KIT
• Manufacturer (Section D): BENVENUE MEDICAL, INC.; 4590 patrick henry drive; santa clara CA 95054
• MDR Report Key: 8356172
• Report Number: 3007033608-2019-00002
• Device Sequence Number: 19256821
• Product Code: MAX
• UDI-Device Identifier: 00813478020322
• UDI-Public: (01)00813478020322(17)181201(10)17243006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: LUN3011-08
• Device Catalogue Number: LUN3011-08
• Device Lot Number: 17243006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention