CONFIDENCE SPINAL CEMENT SYSTEMRecalls & reported problems across all models

We found 11 models of CONFIDENCE SPINAL CEMENT SYSTEM by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 359 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2017 and Sep 30, 2026 — classified as 13 deaths, 52 injuries, 294 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (109 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CONFIDENCE SPINAL CEMENT SYSTEM problems

CONFIDENCE SPINAL CEMENT SYSTEM models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CONFIDENCE SPINAL CEMENT SYSTEM 283910000

  CEMENT, BONE, VERTEBROPLASTY
  5 deaths163 reports
• CONFIDENCE SPINAL CEMENT SYSTEM 283913000

  CEMENT, BONE, VERTEBROPLASTY
  8 deaths146 reports
• CONFIDENCE SPINAL CEMENT SYSTEM 283903611

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  17 reports
• CONFIDENCE SPINAL CEMENT SYSTEM 283903411

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  15 reports
• CONFIDENCE SPINAL CEMENT SYSTEM 283902611

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  6 reports
• CONFIDENCE SPINAL CEMENT SYSTEM 283905000

  CEMENT, BONE, VERTEBROPLASTY
  6 reports
• CONFIDENCE SPINAL CEMENT SYSTEM 283902613

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  2 reports
• CONFIDENCE SPINAL CEMENT SYSTEM 283902411

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  1 report
• CONFIDENCE SPINAL CEMENT SYSTEM 283902413

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  1 report
• CONFIDENCE SPINAL CEMENT SYSTEM 283904413

  NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
  1 report
• CONFIDENCE SPINAL CEMENT SYSTEM 283999002

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent CONFIDENCE SPINAL CEMENT SYSTEM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Chemical Problem

  It was reported that the cement was very tough, could not be mixed as described in the packaging instructions. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948790 ↗
• MalfunctionSep 24, 2026Migration or Expulsion of Device; Failure to Eject

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885539 ↗
• MalfunctionSep 22, 2026Migration or Expulsion of Device

  It was reported that when using Confidence granulation, both stirring and assembly during the procedure went smoothly. Bone cement was poured in, and the rotary pressure doctor felt no pressure and noticed the milk bottle was leaking. They immediately requested a mobile video and urgently contacted the supervisor, deciding to reapply a new CONFIDENCE pack. The surgery was successfully completed with the defective product retained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859061 ↗
• MalfunctionSep 21, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841885 ↗
• MalfunctionSep 9, 2026Break; Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698204 ↗
• MalfunctionSep 2, 2026Migration or Expulsion of Device; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572833 ↗
• MalfunctionSep 2, 2026Migration or Expulsion of Device; Failure to Eject

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564156 ↗
• MalfunctionMay 18, 2026Chemical Problem; Failure to Eject

  DURING THE VERTEBROPLASTY PROCEDURE, THE BONE CEMENT (CONFIDENCE KIT) WAS OPENED AND PREPARED. AT THE TIME OF TRANSFERRING THE PRODUCT TO THE APPLICATION SYSTEM, SIGNIFICANT DIFFICULTY WAS OBSERVED, AND AN INCREASE IN VISCOSITY WAS IDENTIFIED THAT WAS INCOMPATIBLE WITH THE APPROPRIATE HANDLING PHASE. IN VIEW OF THE IMPOSSIBILITY OF USING THE PREPARED MATERIAL, IT WAS DISCARDED ACCORDING TO THE GUIDANCE OF THE HOSPITAL INSTITUTION. THERE WAS NO DAMAGE REPORTED BY THE PATIENT OR USER. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202086 ↗
• MalfunctionMay 15, 2026Migration or Expulsion of Device

  IT WAS REPORTED THE CONFIDENCE CEMENT PUMP LEAKED INSTEAD OF PROPELLING CEMENT NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183840 ↗
• MalfunctionApr 22, 2026Chemical Problem

  INSUFFICIENT MIXING LIQUID: AFTER OPENING THE BOTTLE AND STIRRING, IT CANNOT BE MIXED EVENLY; SOME CEMENT REMAINS IN POWDER FORM. ONLY HALF THE NORMAL USAGE AMOUNT IS SQUEEZED INTO THE BOTTLE. A NEW BOTTLE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957902 ↗
• MalfunctionMar 6, 2026Migration or Expulsion of Device; Failure to Eject

  IT WAS REPORTED THAT WHEN THE BONE CEMENT WAS HALFWAY POURED IN, WATER STARTED LEAKING FROM THE CAP. THE CAP WAS CHECKED AND FOUND TO BE SECURELY LOCKED. THE DOCTOR CONTINUED TO TURN THE PRESSURE GUN, BUT WATER BEGAN SPRAYING OUT OF THE CAP. BECAUSE TOO MUCH WATER WAS BEING LOST FROM THE PRESSURE GUN, THE BONE CEMENT COULD NOT BE POURED IN FURTHER, AND THE ATTENDING PHYSICIAN REQUESTED ANOTHER PACKET. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533483 ↗
• MalfunctionFeb 26, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT FLUID FROM THE PUMP HAS BEEN LEAKING DURING THE APPLICATION OF CEMENT TO THE SCREWS INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460857 ↗
• MalfunctionFeb 26, 2026Crack

  IT WAS REPORTED THAT ON FEBRUARY 13, 2026, THE CEMENT MIXING BOWL CRACKED WHEN THE BOX WAS OPENED. THERE WERE NO REPORTED PATIENT CONSEQUENCES. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456643 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT THE PUMP SYSTEM HAS BURST. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399904 ↗
• MalfunctionFeb 9, 2026Chemical Problem

  IT WAS REPORTED THAT CONFIDENCE KIT, NO NEEDLES, EXPERIENCED A FAILURE IN WHICH THE CEMENT BECAME LUMPY AFTER MIXING, RESULTING IN AN INABILITY TO MIX THE CEMENT PROPERLY. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT DID NOT COME INTO CONTACT WITH THE PRODUCT, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. SURGERY WAS PROLONGED BY EIGHT MINUTES, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A NEW ITEM WAS OPENED. NO FRAGMENTS WERE GENERATED, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292004 ↗

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