CONFIDENCE SPINAL CEMENT SYSTEM 283902413Recalls & reported problems
Medos International Sàrl · CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 13G 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 10705034209418), received between Dec 29, 2021 and Dec 29, 2021 — 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
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2021Break; Break
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VERTEBROPLASTY TREATMENT WAS PERFORMED ON THE CONFIDENCE SYSTEM USING CONFIDENCE CEMENT AND CONFIDENCE NEEDLES. THE NEEDLE WAS INSERTED, THEN THE CEMENT WAS FED THROUGH IT INTO THE SHAFT. ONCE ALL THE CEMENT HAD BEEN INFUSED, WHEN PULLING THE NEEDLE OUT OF THE SHAFT, THE END OF THE NEEDLE BROKE; IT REMAINED DEEP IN THE SHAFT THAT WAS OPERATED ON. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN FRAGMENT. THIS REPORT IS FOR A CONFIDENCE CEMENT NEEDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 13112095 ↗
Other NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE devices
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- N/A 305200Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE99 reports
- PneumoDart TM-317TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall1 report
- TPAK TM-303TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall0 reports
- N/A 305181Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE32 reports
- 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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