MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. LUNA 1.0 IMPLANT KIT, 8-DEGREE, 12MM; 12MM, 8-DEGREE, LUNA 1.0 LORDOTIC IMPLANT KIT

Model Number	LUN3012-08
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/12/2019
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.Root cause of the revision surgery could not be determined as no other information was available for investigation.Benvenue will continue to seek out more information and will file a supplemental mdr if necessary.A review of the lot history record confirmed no manufacturing nonconformities were issued to the reported lot that would have caused or contributed to this event.Based on a review of the information provided, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
On august 12, 2019, benvenue received information indicating that a revision surgery took place to remove a luna implant due to pain.Date of index surgery was (b)(6) 2017.Revision surgery date is unknown.

• Brand Name: LUNA 1.0 IMPLANT KIT, 8-DEGREE, 12MM
• Common Device Name: 12MM, 8-DEGREE, LUNA 1.0 LORDOTIC IMPLANT KIT
• Manufacturer (Section D): BENVENUE MEDICAL, INC.; 4590 patrick henry drive; santa clara CA 95054
• MDR Report Key: 8997517
• Report Number: 3007033608-2019-00004
• Device Sequence Number: 3380028
• Product Code: MAX
• UDI-Device Identifier: 00813478020339
• UDI-Public: (01)00813478020339(17)190427(10)17117001
• Combination Product (Y/N): N
• PMA/510(K) Number: K162431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 04/27/2019
• Device Model Number: LUN3012-08
• Device Catalogue Number: LUN3012-08
• Device Lot Number: 17117001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/11/2019
• 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