MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. LUNA 1.0 IMPLANT KIT, 8-DEGREE, 11MM; 11MM, 8-DEGREE, LUNA 1.0 LORDOTIC IMPLANT KIT

Model Number	LUN3011-08
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/28/2018
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.On (b)(6) 2018, revision surgery was performed, and the surgeon was able to remove the implant uneventfully.The removed implant was retained by the hospital.Based on the available data, the root cause was determined to be a failure of the shape lock mechanism (lock wire) during a traumatic event (fall) combined with incomplete intraoperative assembly (no interlock between top and middle).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.
Event or Problem Description
On january 3, 2019, benvenue received information of a patient with an index surgery of (b)(6) 2018 had a severe fall recently that led to pain and implant migration that was resolved uneventfully via an alif approach on (b)(6) 2018.The removed implant was retained by the hospital.

• Brand Name: LUNA 1.0 IMPLANT KIT, 8-DEGREE, 11MM
• Common Device Name: 11MM, 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: 8278788
• Report Number: 3007033608-2019-00001
• Device Sequence Number: 19413708
• Product Code: MAX
• UDI-Device Identifier: 00813478020322
• UDI-Public: (01)00813478020322(17)190526(10)17146001
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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: 05/26/2019
• Device Model Number: LUN3011-08
• Device Catalogue Number: LUN3011-08
• Device Lot Number: 17146001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/25/2019
• 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