CONFIDENCE SPINAL CEMENT SYSTEM 283902411Recalls & reported problems
Medos International Sàrl · CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 11G x 4 Inches · Class 1
All models of CONFIDENCE SPINAL CEMENT SYSTEM (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034209401), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Injury1
- No Code Available1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 19, 2018Break; Break
PER REPORTER: PATIENT CAME IN TO GET A VERTEBROPLASTY IN THE ANGIOGRAPHY SUITES. THIS IS A ROUTINE PROCEDURE THAT THE NEURORADIOLOGIST DOES. THEY HAD PUT CEMENT IN ON ONE SIDE AND WAS READY TO DO THE SAME ON THE OTHER SIDE OF THE VERTEBRAL BODY. HOWEVER AS THEY WERE ABOUT TO TAKE OUT THE BEVELED TIP INTRODUCER TO REPLACE IT WITH THE CEMENT INTRODUCER- THEY COULD NOT TAKE IT OUT. AFTER ATTEMPTS, THE HANDLE CAME OFF, LEAVING THE NEEDLE IN THE VERTEBRAL BODY. WE TRIED VARIOUS WAYS OF TAKING THE NEEDLE OUT ¿ INCLUDING SLAPHAMMER, DIFFERENT FORCEPS (KELLY, KOCHERS), DIFFERENT ROD HOLDERS BUT IN THE END THEY HAD TO TRANSFER THE PATIENT UP TO MAIN THEATRES WHERE A NEUROSPINAL CONSULTANT OPENED UP THE PATIENT. HE SUCCESSFULLY RETRIEVED THE NEEDLE BY DRILLING AROUND IT AND THEN PULLING IT OUT. BOTH DOCTORS MADE MENTION THAT THE PATIENT IS HIGHLY SCLEROTIC MAKING THE BONE VERY HARD.
Patient problems: Injury; No Code Available; Tissue Damage
MAUDE report 7986235 ↗
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- SOL-M™ Blunt Fill Needle with 5 Micron Filter 110022Sol-Millennium Medical, Inc. · Needle, Aspiration And Injection, Disposable17 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283903611Medos International Sàrl · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE17 reports
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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