SentioMMG 2006Recalls & reported problems
Innovative Surgical Solutions LLC · Navigational Sterile Disposables · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853926005006), received between May 11, 2020 and May 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Device Alarm System1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2020Device Alarm System; Device Alarm System
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THERE WAS A FIVE (5) TO TEN (10) SECOND DELAYED RESPONSE IN THE SYSTEM REPORTING MECHANOMYOGRAM (MMG) EVENTS. THE PATIENT CAN BE SEEN MOVING BUT THE SYSTEM DOESN¿T SEND AN ALERT FOR IMMEDIATELY. THIS HAS HAPPENED ON THREE (3) CASES DURING A TWO (2) WEEK PERIOD. THE SYSTEM HAD BEEN PERFORMING SUCCESSFULLY PRIOR TO THESE SURGERIES. THE SYSTEM IS THE MMGB 81. DURING THE CORTICAL PEDICLE SCREW INSERTION, THE DRILL IS STIMULATED WHILE DRILLING AND THEN THE BALL TIP IS USED TO PROBE THE HOLE. THE SCREW IS STIMULATED AT THE END. THIS LAG HAS BEEN PRESENT AT ALL STEPS, NOT ONE IN PARTICULAR. THERE WAS NO EXCESSIVE ENERGY ALERT. L4-5 ARE THE USUAL LEVELS THEY ARE STIMULATING. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) SENTIO NAVIGATION PROBE. THIS IS REPORT 4 OF 5 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10045072 ↗
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- SENTIO 286202400Medos International Sàrl · Neurosurgical nerve locator2 reports
- SENTIO 286202108Medos International Sàrl · Neurosurgical nerve locator2 reports
- NVM5 NVM5MULTIEVALNuvasive, Inc. · Neurosurgical nerve locator1 report
- ALARA Neuro Access Needle Kit AAN-09-2NSSurgentec, LLC · Neurosurgical Nerve Locator1 report
- Neurosign V4 Intraoperative Nerve Monitor 4230-00The Magstim Company Limited · Neurosurgical Nerve Locator1 report
- BMAN Solid Diamond Needle SR07-1100Surgentec, LLC · Neurosurgical Nerve Locator1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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