Neurosign 100 9883-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060229530943), received between Jul 3, 2018 and Jul 3, 2018 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K923056); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  PATIENT (B)(6) (F, (B)(6)), UNDERWENT A STAPEDECTOMY SURGERY INDICATED FOR OTOSCLEROSIS ON THE (B)(6) 2018. THE PATIENT HAD AN ABERRANT FACIAL NERVE. DURING THE SURGERY A NEUROSIGN 100 AND A NEUROSIGN CONCENTRIC PROBE WERE USED FOR NERVE MONITORING. AS REPORTED BY THE CUSTOMER, THE DEVICE DID NOT IDENTIFY DIRECT STIMULATION OR MANIPULATION OF THE NERVE. THE PATIENT WAS REVIEWED IN THE RECOVERY UNIT (PACU) AFTER THE SURGERY, WHERE THE SURGEON NOTICED FACIAL ASYMMETRY, OR ALSO REPORTED AS PARTIAL FACIAL PALSY, WHICH COULD POTENTIALLY BE A PERMANENT INJURY.

  Patient problems: Facial Nerve Paralysis

  MAUDE report 7657792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923056. One submission often covers many models, so check the product and lot details in each record.

• Z-0869-2021 · Dec 8, 2020 · Terminated
  Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial ner