CONFIDENCE SPINAL CEMENT SYSTEM 283904413Recalls & reported problems
Medos International Sàrl · CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, SIDE HOLE 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 10705034209524), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE KYPHOPLASTY, THE TIP OF THE SIDE HOLE NEEDLE WAS BROKE-OFF AND REMAINED IN THE PATIENT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WERE FRAGMENTS GENERATED BUT NO PLANS IN REMOVING THE REMAINING BROKEN PARTS IN THE PATIENT. THE PATIENT STATUS IS GOOD. THE PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) UNK - DRILL BITS: TRAUMA. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 11240114 ↗
Other NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE devices
- N/A 305211Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE425 reports
- N/A 305180Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE300 reports
- 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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