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

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	01/27/2017
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 l3-l4.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, is properly zipped, is fully seated and is properly locked.There is a minor amount of slack remaining in the lock wire, but that would not have contributed to this failure.Therefore, the root cause of this failure cannot be 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.
Event or Problem Description
On (b)(6) 2017, the company was made aware that in a follow-up radiographic exam at 8 weeks post-op of a patient that had a fusion surgery where the luna implant was used, revealed that the luna 12mm lordotic implant had disassembled, with the middle migrating posteriorly into the spinal canal.Since the migration was causing the patient significant pain, revision surgery was scheduled.No additional information were provided at that time and the company is seeking additional information.

• Brand Name: LUNA 3D LORDOTIC IMPLANT KIT
• Common Device Name: 12MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT, PRODUCT CODE: MAX
• Manufacturer (Section D): BENVENUE MEDICAL INC; 5403 betsy ross dr; santa clara CA 95054 9023
• MDR Report Key: 6389239
• Report Number: 3007033608-2017-00002
• Device Sequence Number: 454643
• Product Code: MAX
• UDI-Device Identifier: 00813478020339
• UDI-Public: (01)00813478020339(17)170328(10)16272002
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 03/08/2017
• 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