EXPEDIUM VERSE 299704215Recalls & reported problems
Medos International Sàrl · EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE · Class 1
All models of EXPEDIUM VERSE (90)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Synthes Expedium Verse Quick Stick sleeve is a surgical instrument used to fit and handle parts of the Expedium Verse spine system during spine surgery. The 32 reports mostly describe the sleeve bending or twisting, not fitting properly onto screws and other instruments, or breaking, and several say the two-piece instrument could not be taken apart again after assembly — mostly noticed during training, instrument presentations or cleaning, with no patient involved. There are 2 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705034467566), received between Aug 27, 2019 and Mar 22, 2024 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (28 reports).
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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility28
- Material Twisted/Bent24
- Break2
- Connection Problem2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Code Available2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT 2 INSTRUMENTS THAT ARE TOTALLY NEW AND NEVER USED, WERE NOT ABLE TO BE DISMANTLED ONCE ASSEMBLED. THEY CONSIST OF 2 PARTS. THE ISSUE WAS DISCOVERED DURING INSTRUMENT PRESENTATION AT CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18959452 ↗MalfunctionMar 22, 2024Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SPINE REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT 2 INSTRUMENTS THAT ARE TOTALLY NEW AND NEVER USED, WERE NOT ABLE TO BE DISMANTLED ONCE ASSEMBLED. THEY CONSIST OF 2 PARTS. THE ISSUE WAS DISCOVERED DURING INSTRUMENT PRESENTATION AT CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18959434 ↗MalfunctionAug 8, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS BENT, AND GETS STUCK ON THE MAIN TOWER. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS NOTED DURING STAFF TRAINING IN THE OFFICE. THIS REPORT INVOLVES ONE EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17479689 ↗MalfunctionAug 2, 2023Break; Break
DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING AN UNKNOWN PROCEDURE, THE PRODUCTS IN QUESTION WERE FOUND TO BE BROKEN/DEFECTIVE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 4 OF 8 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17445709 ↗MalfunctionFeb 12, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE VERSE QUICK STICK SLEEVE AND VERSE QUICK STICK TUBE COULD NOT BE FITTED ONTO THE IMPLANT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT INSTRUMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11324306 ↗MalfunctionJan 7, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
THIS REPORT IS 1 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11131345 ↗MalfunctionJan 6, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD. THE TIP OF THE INSERTER APPEARED STRIPPED. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 7 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125772 ↗MalfunctionJan 6, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD. THE TIP OF THE INSERTER APPEARED STRIPPED. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 6 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125746 ↗MalfunctionJan 6, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD. THE TIP OF THE INSERTER APPEARED STRIPPED. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 5 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125673 ↗MalfunctionJan 6, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD. THE TIP OF THE INSERTER APPEARED STRIPPED. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 4 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125482 ↗MalfunctionJan 6, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD. THE TIP OF THE INSERTER APPEARED STRIPPED. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 3 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125455 ↗MalfunctionJan 6, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD. THE TIP OF THE INSERTER APPEARED STRIPPED. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 2 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125422 ↗MalfunctionJan 6, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE CLEANING PROCESS, THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD. THE TIP OF THE INSERTER APPEARED STRIPPED. THERE WAS NO SURGICAL IMPACT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VERSE QUICK STICK, SLEEVE. THIS IS REPORT 1 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125301 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118956 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118914 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118908 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118900 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118881 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118849 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118826 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118798 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118630 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118483 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118450 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE CLEANING PROCESS IT WAS NOTICED THAT THE QUICK STICK SLEEVE DID NOT FIT PROPERLY ON THE TOP NOTCH OF THE SCREW HEAD ANYMORE. THE TIP OF INSERTER APPEARS TO BE STRIPPED. THERE WAS NO SURGICAL OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM VERSE SPINE SYSTEM QUICK STICK, SLEEVE. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118429 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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