MAUDE Adverse Event Report: BENVENUE MEDICAL INC LUNA; LUNA 3D 8-DEGREE 14MM IMPLANT

Model Number	LUN3014-08
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/17/2017
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.Available images of the original procedure and at subsequent post-op time points were reviewed.It appears that the implant was not fully locked at the time of implantation, with the middle component not fully seated in the groove with the implant outers.In addition, the lock wire looks to be broken at its joint with the backstop.Since the primary locking feature (engagement of the middle component into the outer components) and the secondary locking feature (the lock wire) both failed, there was no means to prevent migration of the middle member.Reviewing the images of the retrieved device confirmed that the implant was not properly locked.These intraoperative factors would explain implant disassembly and migration.A review of the lot history record confirmed no manufacturing nonconformities issued to the reported lot that would have caused or contributed to this event.This appears to be an isolated incident and will be monitored.
Event or Problem Description
During a follow-up visit at 17 weeks post-op on (b)(6) 2017, radiographs revealed that a luna 14 mm lordotic implant at l5/s1 had disassembled, with the middle migrating posteriorly into the spinal canal and creating pain.The physician decided to revise that level via an anterior approach.

• Brand Name: LUNA
• Common Device Name: LUNA 3D 8-DEGREE 14MM IMPLANT
• Manufacturer (Section D): BENVENUE MEDICAL INC; 5403 betsy ross dr; santa clara CA 95054 1145
• MDR Report Key: 6410812
• Report Number: 3007033608-2017-00004
• Device Sequence Number: 13571872
• Product Code: MAX
• UDI-Device Identifier: 00813478020353
• UDI-Public: 0100813478020353171701221016203009
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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: 01/22/2017
• Device Model Number: LUN3014-08
• Device Catalogue Number: LUN3014-08
• Device Lot Number: 16203009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/16/2017
• 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