MAUDE Adverse Event Report: NEXXT SPINE LLC HONOUR SPACER SYSTEM

Model Number	21-229-10
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Peek implant of height 10mm migrated as noticed in an x-ray in 2 week post-op follow up visit.Surgeon performed a revision surgery to replace the 10mm implant with an 11mm implant as a better fit.

• Brand Name: HONOUR SPACER SYSTEM
• Common Device Name: HONOUR SPACER SYSTEM
• Manufacturer (Section D): NEXXT SPINE LLC; 14425 bergen blvd; suite b; noblesville IN 46060 3422
• MDR Report Key: 8002286
• Report Number: 3007922509-2018-00005
• Device Sequence Number: 1301482
• Product Code: MAX
• UDI-Device Identifier: 00889929001936
• UDI-Public: 00889929001936
• Combination Product (Y/N): N
• PMA/510(K) Number: K120345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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 Model Number: 21-229-10
• Device Catalogue Number: 21-229-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/24/2018
• 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
• Patient Age: 50 YR