MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. LUNA 3D LORDOTIC 8 DEGREE IMPLANT KIT, 13 MM; 13MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT

Model Number	LUN3013-08
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	11/30/2017
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.A definitive root cause for this device failure could not be determined due to device not being returned for investigation.However, based on the imaging, the intraoperative factors that may have contributed to the implant disassembly and migration include: improper positioning of the device, incomplete deployment of the middle component, possible inadequate posterior fixation, and possible incorrect sizing.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.
Event or Problem Description
On (b)(6) 2017, the company became aware of a revision surgery performed that day due to patient experiencing increased symptomatic pain.It was further learned that the original case was completed on (b)(6) 2017.Based on provided images, it appears that the luna device had slightly migrated posteriorly at the first follow-up at 1-month post-op.At around the 6-months post-operation follow-up, the patient experienced a fall with increased symptomatic radiculopathy pain.At that time, imaging showed that the middle member of the luna device had partially disassembled and further migrated posteriorly into the spinal canal.During the revision surgery, the implant was not safely retrievable and as a consequence, it was left in place and further bony decompression around the canal was performed.Procedure continued successfully with no other issues.No fluoro was taken on day of revision.

• Brand Name: LUNA 3D LORDOTIC 8 DEGREE IMPLANT KIT, 13 MM
• Common Device Name: 13MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT
• Manufacturer (Section D): BENVENUE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 7141406
• Report Number: 3007033608-2017-00009
• Device Sequence Number: 16462584
• Product Code: MAX
• UDI-Device Identifier: 00813478020346
• UDI-Public: (01)00813478020346(17)190215(10)17046002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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: 02/15/2019
• Device Model Number: LUN3013-08
• Device Catalogue Number: LUN3013-08
• Device Lot Number: 17046002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/21/2017
• 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