MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. LUNA 3D LORDOTIC 8 DEGREE IMPLANT KIT, 15 MM; 15MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT

Model Number	LUN3015-08
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/13/2017
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.Upon review of the available images, the original procedure report and returned device investigation, it appears that the implant was not fully seated and locked at the time of original implantation.Upon analysis of the returned implant, these suspected causes of disassembly and migration were confirmed.The clean edges on the snap lock recesses confirm that the implant was likely never fully seated, and the failure marks on the lock wire inside the device confirm that the implant was not locked, likely due to an over-tension situation.These intraoperative factors would explain implant disassembly and migration.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 and product returned, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
On (b)(6) 2017, the company became aware of a revision surgery performed that same day to remove an implant that had disassembled and migrated posteriorly.The original case was completed on (b)(6) 2017.Follow the original surgery, patient presented with continued right leg pain.Standard x-rays showed the middle member component has displaced.During the revision surgery, the implant was removed safely without incident.Intra-op fluoro was taken on day of revision.

• Brand Name: LUNA 3D LORDOTIC 8 DEGREE IMPLANT KIT, 15 MM
• Common Device Name: 15MM, 8-DEGREE, LUNA 3D LORDOTIC IMPLANT KIT
• Manufacturer (Section D): BENVENUE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• MDR Report Key: 7184637
• Report Number: 3007033608-2018-00002
• Device Sequence Number: 19129112
• Product Code: MAX
• UDI-Device Identifier: 00813478020360
• UDI-Public: (01)00813478020360(17)190118(10)17018003
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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: 01/18/2019
• Device Model Number: LUN3015-08
• Device Catalogue Number: LUN3015-08
• Device Lot Number: 17018003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/11/2018
• 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