NA 03.804.413SRecalls & reported problems
Synthes (U.S.A.) LP · INFLATION SYSTEM-STERILE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034722597), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K110604); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inflation Problem1
- Material Integrity Problem1
Patient problems
- 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.
MalfunctionDec 2, 2025Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem
IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY PERFORMED ON NOV 12, 2025. WHEN THE SURGEON TRIED TO INFLATE THE BALLOON, THE BALLOON SUDDENLY BECAME UNABLE TO INFLATE. THE BALLOON BROKE WHEN THE STENT WAS SLIGHTLY INFLATED, AND IT HAD TO BE REMOVED. THE TRIAL BALLOON AND STENT BALLOON WERE INFLATED AT THE SAME LOCATION, AND SINCE THIS WAS A FRESH FRACTURE, IT WAS UNLIKELY THAT HARD BONE WAS HIT. BASED ON THE LOCATION OF THE DAMAGE, IT APPEARS THAT THE DAMAGE OCCURRED WHEN ATTEMPTING TO INFLATE THE CRIMPED STENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. AFTER SURGERY, THE DAMAGED BALLOON WAS INFLATED, BUT DAMAGE WAS CONFIRMED APPROXIMATELY 2 MM FROM THE TIP. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23694990 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110604. One submission often covers many models, so check the product and lot details in each record.
- Z-0877-2015 · Oct 6, 2014 · TerminatedSynthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to creat
Other CEMENT, BONE, VERTEBROPLASTY devices
- CONFIDENCE SPINAL CEMENT SYSTEM 283910000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY5 deaths163 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283913000Medos International Sàrl · CEMENT, BONE, VERTEBROPLASTY8 deaths146 reports
- KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01BMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY3 deaths67 reports
- SYNFLATE 03.804.701SSynthes GmbH · CEMENT, BONE, VERTEBROPLASTY60 reports
- KYPHON® HV-R® Bone Cement C01AMedtronic Sofamor Danek, Inc. · CEMENT, BONE, VERTEBROPLASTY57 reports
- iVAS 0705315000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- Cortoss 2101-0005Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall3 reports
- iVAS 0705310000Stryker Corporation · CEMENT, BONE, VERTEBROPLASTY1 recall1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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