MAUDE Adverse Event Report: ACCLARENT, INC. SPINPLUS NAV 6x16mm 3 Guide; Relieva

Catalog Number	RSP0616MFSN
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that initially the spinplus nav 6x16mm 3 guide (b)(6) "was tracking accurately until midway through the case it stopped being accurate." inaccuracy was reportedly determined by "trying to get into frontal and showed the balloon in the brain.Inaccuracy was observed posterior.It was "off by 5 mm or more and then stopped tracking altogether".Staff opened a new spinplus which was accurate from then on.There was no patient injury or delay in surgery.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: SPINPLUS NAV 6x16mm 3 Guide
• Common Device Name: Relieva
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; 31 technology drive; CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine; CA 92618
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50893073
• Report Number: 3003418325-2026-00042
• Device Sequence Number: 13452320
• Product Code: PGW
• UDI-Device Identifier: 10705031241015
• UDI-Public: 10705031241015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 251015E-PC
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown