MAUDE Adverse Event Report: BENVENUE MEDICAL, INC LUNA 3D LORDOTIC 8 DEGREE IMPLANT KIT, 12 MM; 12MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT

Model Number	LUN3012-08
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/24/2017
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 were reviewed and revealed that the patient had uneventful placement of a luna cage at the indicated level l5/s1.Based on imaging only since no returned implant was provided, there are no intra-operative factors that would explain implant migration.The luna implant appears to be properly positioned and is properly zipped.However, the implant appears to not be fully seated, but it is properly locked.It is unknown if the incomplete seating contributed to this failure, considering that the implant was properly locked.Therefore, the root cause of this failure cannot be definitively determined.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.Based on review of the information provided, there is no indication of a product quality issue with respect to manufacture, design or labeling.No additional information was provided.Device not returned to manufacturer.
Event or Problem Description
On (b)(4) 2017, the company became aware of a luna device disassembled post-operatively and the middle member migrated posteriorly.Disassembly and subsequent migration occurred sometime between the original case and 6-weeks post-op.At the time of the event, revision surgery was to be determined.Since the migration was causing the patient pain, revision surgery was scheduled and completed on (b)(6) 2017.Implant was removed successfully and replaced by another luna device at the same level.All symptoms returned to normal post re-operation.

• Brand Name: LUNA 3D LORDOTIC 8 DEGREE IMPLANT KIT, 12 MM
• Common Device Name: 12MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT
• Manufacturer (Section D): BENVENUE MEDICAL, INC; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 6590058
• Report Number: 3007033608-2017-00006
• Device Sequence Number: 369485
• Product Code: MAX
• UDI-Device Identifier: 00813478020339
• UDI-Public: (01)00813478020339(17)170328(10)167272002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: LUN3012-08
• Device Catalogue Number: LUN3012-08
• Device Lot Number: 16272002 OR 16327002
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/25/2017
• 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