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

Model Number LUN3014-08

Device Problem Missing Value Reason (3192)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/17/2017

Event Type  Injury  

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 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
• Type of Device: LUNA 3D 8-DEGREE 14MM IMPLANT
• Manufacturer (Section D): BENVENUE MEDICAL INC; 5403 betsy ross dr; santa clara CA 95054 1145
• Manufacturer (Section G): BENVENUE MEDICAL INC; 5403 betsy ross dr; santa clara CA 05054 1145
• Manufacturer Contact: laurent schaller ; 5403 betsy ross dr; santa clara, CA 95054-1145
• MDR Report Key: 6410812
• MDR Text Key: 70122226
• Report Number: 3007033608-2017-00004
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00813478020353
• UDI-Public: 0100813478020353171701221016203009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention