SENTIO 286202108Recalls & reported problems
Medos International Sàrl · SENTIO MMG SENSORS 8 PACK WITH GROUND · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705034534753), received between Dec 2, 2019 and May 11, 2020 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Alarm System1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 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) MMG SENSORS 8 PK W GROUND. THIS IS REPORT 5 OF 5 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10045091 ↗MalfunctionDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON (B)(6) 2019, SENTIO SYSTEM HAD A SENSOR FAULT ERROR. THERE WAS NO REPORTED PATIENT COMPROMISED EVENT AS PART OF THE ERRORS EXPERIENCED. THE PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9398242 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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