SENTIO 286202400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034534794), received between May 11, 2020 and Aug 5, 2021 — classified as 1 injury, 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT UNDERWENT L4/5 MICRODISCECTOMY PROCEDURE. POSTOPERATIVELY THE SURGEON NOTED THE POSTERIOR SPINE DECOMPRESSIONS WHEREBY THE PATIENT HAS DEVELOPED CAUDA EQUINA SYNDROME WITH BILATERAL ABDUCTOR WEAKNESS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SENTIO MMG CONTROL UNIT. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fatigue; Nerve Damage

  MAUDE report 12281503 ↗
• 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 CONTROL BOX. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10044957 ↗