SYNFLATE 03.804.700SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034722702), received between Oct 4, 2021 and Feb 5, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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, 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Inflation Problem

  IT WAS REPORTED THAT THIS WAS AN BKP PERFORMED ON (B)(6) 2026. DURING THE SURGERY, THE GUIDE WIRE ATTACHED TO THE BALLOON PIERCED THE BALLOON, MAKING INFLATION IMPOSSIBLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268794 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(L1) FOR OSTEOPOROTIC VERTEBRAL FRACTURE ON (B)(6) 2025. THE SALES REP WAS INFORMED FROM THE NURSE. THE BALLOON AND INFLATION SYSTEM WERE PREPARED AND CONNECTED ACCORDING TO THE PROCEDURE MANUAL. WHEN THE BALLOON WAS INSERTED INTO THE VERTEBRAL BODY AND INFLATED, INFLATION FLUID LEAKED OUT FROM NEAR THE SYNTHESIS MARK, NEAR THE CONNECTION BETWEEN THE BALLOON AND INFLATION SYSTEM. CONSIDERING THE POSSIBILITY OF A POOR CONNECTION, THE CONNECTION WAS TIGHTENED FIRMLY AND THE SCREWS ON THE AUXILIARY WIRE WERE ALSO CONFIRMED TO BE TIGHT. SINCE IT STILL LEAKED, IT WAS NOT FROM THE CONNECTION WITH THE INFLATION SYSTEM, BUT FROM A PLACE WHERE IT CLEARLY SHOULD NOT HAVE LEAKED. THE LEAKED INFLATION FLUID WAS IN A NEAT, STRAIGHT LINE. AS THE BALLOON WOULD NOT INFLATE, IT WAS ABANDONED. THE SURGEON DECIDED THAT THE BALLOON ON THE OTHER SIDE WAS FUNCTIONING NORMALLY, SO IT WAS REMOVED AND REUSED TO REDUCE THE VERTEBRAL BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816798 ↗
• MalfunctionSep 4, 2025Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (L3) PERFORMED ON (B)(6) 2025. THE BALLOON WAS ATTACHED OUTSIDE THE SURGICAL FIELD AND INSERTED FROM THE RIGHT SIDE. WHEN THE BALLOON WAS INFLATED, THE PRESSURE SUDDENLY DROPPED, AND THAT CAUSED THE BALLOON TO BREAK AND RESULTING IN INSUFFICIENT INFLATION. AS THE BALLOON BROKE ON THE RIGHT SIDE IN ALL THREE CASES, VERTEBRAL EXPANSION WAS NOT POSSIBLE AND THE SURGERY WAS TERMINATED BY ONLY INJECTING CEMENT AND COMPLETED SUCCESSFULLY WITHIN 30 MINS OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964491 ↗
• MalfunctionSep 4, 2025Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (L3) PERFORMED ON (B)(6) 2025. THE BALLOON WAS ATTACHED OUTSIDE THE SURGICAL FIELD AND INSERTED FROM THE RIGHT SIDE. WHEN THE BALLOON WAS INFLATED, THE PRESSURE SUDDENLY DROPPED, AND THAT CAUSED THE BALLOON TO BREAK AND RESULTING IN INSUFFICIENT INFLATION. AS THE BALLOON BROKE ON THE RIGHT SIDE IN ALL THREE CASES, VERTEBRAL EXPANSION WAS NOT POSSIBLE AND THE SURGERY WAS TERMINATED BY ONLY INJECTING CEMENT AND COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964091 ↗
• MalfunctionSep 4, 2025Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY (L3) PERFORMED ON (B)(6), 2025. THE BALLOON WAS ATTACHED OUTSIDE THE SURGICAL FIELD AND INSERTED FROM THE RIGHT SIDE. WHEN THE BALLOON WAS INFLATED, THE PRESSURE SUDDENLY DROPPED, AND THAT CAUSED THE BALLOON TO BREAK AND RESULTING IN INSUFFICIENT INFLATION. AS THE BALLOON BROKE ON THE RIGHT SIDE IN ALL THREE CASES, VERTEBRAL EXPANSION WAS NOT POSSIBLE AND THE SURGERY WAS TERMINATED BY ONLY INJECTING CEMENT AND COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964046 ↗
• MalfunctionJul 21, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, THE SURGEON INFLATED THE SYNFLATE BALLOON INSIDE THE VERTEBRAL BODY, REMOVE IT, AND THEN ATTEMPTED TO REINSERT THE SYNFLATE BALLOON INTO THE VERTEBRAL BODY. HOWEVER, IT COULD NOT BE INSERTED INTO THE TROCAR. ANOTHER BALLOON WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561116 ↗
• MalfunctionJun 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY PERFORMED ON (B)(6) 2025. THE BALLOON WAS OPENED BEFORE THE START OF THE SURGERY DURING THE PRELIMINARY PREPARATIONS. AT THAT TIME, IT WAS CONFIRMED THAT THE BALLOON'S VALVE CAP WAS DAMAGED. THEREFORE, A NEW BALLOON WAS OPENED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328054 ↗
• MalfunctionAug 14, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT BKP FOR THORACIC COMPRESSION FRACTURE. DURING INFLATION OF THE BALLOON, THERE WAS A CRACK IN THE UPPER PART OF THE BALLOON SHAFT FROM WHICH CONTRAST AGENTS LEAKED. THE BALLOON IN QUESTION COULD NOT BE INFLATED, SO A NEW BALLOON WAS OPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNFLATE BALLOON/SMALL- STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540214 ↗
• MalfunctionNov 18, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE BALLOON IN QUESTION SEEMED TO BREAK DURING DEPLOYMENT. CONTRAST WAS SEEN OUTSIDE OF THE BALLOON INTRAOP AND THE BALLOON WOULD NOT INFLATE. PATIENT INVOLVEMENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNFLATE BALLOON/SMALL- STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825732 ↗
• MalfunctionNov 30, 2021Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SURGEON NOTICED THAT WHERE REVIEWING X-RAY, THE SYNFLATE VERTEBRAL BALLOON LEAKED FLUID AT THE JUNCTION OF THE BALLOON WITH THE STYLET. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK STYLET (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SYNFLATE BALLOON/SMALL STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12900854 ↗
• MalfunctionOct 4, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT A KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE THE SURGEON HAD AN ISSUE OF GETTING VERTECEM BALLOON TO INFLATE. SURGEON THOUGHT MAYBE SOMETHING WRONG WITH ATTACHMENT TO BALLOON. SURGEON WAS ABLE TO GET IT INFLATED ENOUGH TO RESTORE THE HEIGHT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SLIGHT DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) SYNFLATE BALLOON/SMALL- STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569230 ↗