MAUDE Adverse Event Report: BENVENUE MEDICAL INC. LUNA 3D LORDOTIC IMPLANT KIT; 11MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT

Model Number	LUN3011-08
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	08/24/2016
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 procedural images were reviewed and revealed that the patient had uneventful placement of a luna cage at the indicated degenerative disc disease level with a spondylolisthesis of grade 1 to 2 and the condition was well corrected.Additionally, a benvenue medical director reviewed the event and images as follows: recurrence of anterior subluxation with anterior cage migration following the upper vertebral body without evidence of cage failure.The implant post-removal appeared fully intact based on available photographs.Because of symptoms, the indicated level was appropriately revised without event.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
The initial luna procedure was performed uneventfully for the l4/5 level and no device malfunction was reported.Past two month post-op, patient recurring pain was reported.Follow-up imaging revealed that the implant was positioned anteriorly, and a revision procedure was scheduled.The reoperation was uneventful and the device was explanted and replaced with a cage from another manufacturer via an anterior approach.Product was not returned for investigation but photos provided illustrated that the implant was intact.There was no additional information provided.

• Brand Name: LUNA 3D LORDOTIC IMPLANT KIT
• Common Device Name: 11MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT
• Manufacturer (Section D): BENVENUE MEDICAL INC.; 5403 betsy ross drive; santa clara CA 95054 1145
• MDR Report Key: 5982274
• Report Number: 3007033608-2016-00007
• Device Sequence Number: 84731
• Product Code: MAX
• UDI-Device Identifier: 00813478020322
• UDI-Public: (01)00813478020322(17)161105(10)16126002
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2016

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: 11/05/2016
• Device Model Number: LUN3011-08
• Device Catalogue Number: LUN3011-08
• Device Lot Number: 16126002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 09/27/2016
• 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