SYNFLATERecalls & reported problems across all models

We found 3 models of SYNFLATE by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2018 and May 19, 2026 — classified as 2 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (39 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 SYNFLATE problems

SYNFLATE models

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

• SYNFLATE 03.804.701S

  CEMENT, BONE, VERTEBROPLASTY
  60 reports
• SYNFLATE 03.804.700S

  ARTHROSCOPE
  11 reports
• SYNFLATE 03.804.702S

  CEMENT, BONE, VERTEBROPLASTY
  10 reports

Recent SYNFLATE adverse event reports

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

• MalfunctionMay 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS A VERTEBROPLASTY FOR A VERTEBRAL FRACTURE ON (B)(6) 2026. THE BALLOON COULD NOT BE INSERTED INTO THE WORKING SLEEVE. THE NEGATIVE PRESSURE OPERATION WAS PERFORMED, AND INSERTION WAS TRIED MULTIPLE TIMES, BUT THE BALLOON STILL COULD NOT BE INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY USING ANOTHER NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219674 ↗
• MalfunctionMay 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT SYNFLATE VERTEBRAL BALLOON MED WAS INVOLVED IN AN INTRAOPERATIVE EVENT DURING A BALLOON KYPHOPLASTY PROCEDURE. THE REPORTED FAILURE INVOLVED THE BALLOON TEARING DURING INFLATION, RESULTING IN CONTRAST MEDIUM DISPERSING WITHIN THE VERTEBRAL BODY, LIKELY DUE TO CONTACT WITH A BONE EDGE. WHEN ATTEMPTING TO REMOVE THE DAMAGED BALLOON, A PORTION TORE OFF AND REMAINED IN SITU. THIS LED TO A 30-MINUTE SURGICAL DELAY, REQUIRED ADDITIONAL X-RAYS AND CT IMAGING, NECESSITATED AN EXTENSION OF ACCESS, AND RESULTED IN INCREASED BLOOD LOSS AND A HIGHER RISK OF INFECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25160795 ↗
• MalfunctionMay 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT SYNFLATE VERTEBRAL BALLOON MED WAS INVOLVED IN AN INTRAOPERATIVE EVENT DURING A BALLOON KYPHOPLASTY PROCEDURE. THE REPORTED FAILURE INVOLVED THE BALLOON TEARING DURING INFLATION, RESULTING IN CONTRAST MEDIUM DISPERSING WITHIN THE VERTEBRAL BODY, LIKELY DUE TO CONTACT WITH A BONE EDGE. WHEN ATTEMPTING TO REMOVE THE DAMAGED BALLOON, A PORTION TORE OFF AND REMAINED IN SITU. THIS LED TO A 30-MINUTE SURGICAL DELAY, REQUIRED ADDITIONAL X-RAYS AND CT IMAGING, NECESSITATED AN EXTENSION OF ACCESS, AND RESULTED IN INCREASED BLOOD LOSS AND A HIGHER RISK OF INFECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25160727 ↗
• MalfunctionFeb 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS A BKP +FIXATION(L3) PERFORMED ON (B)(6) 2026. WHEN THE SURGEON TRIED TO INSERT THE BALLOON INTO THE WORKING SLEEVE, IT WOULDN'T GO IN. THE SURGEON USED A DIFFERENT ONE AND IT WORKED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390664 ↗
• 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 ↗
• MalfunctionJan 27, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE ON (B)(6) 2026. AFTER DEFLATION, DIFFICULTY IN REMOVING THE BALLOONS OCCURRED ON BOTH SIDES. DESPITE TRYING TO RESOLVE THE ISSUE, THE BALLOONS COULD NOT BE REMOVED, SO THE SURGEON REMOVED THE WORKING SLEEVE, AND THE BALLOONS WERE CUT AND REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189263 ↗
• MalfunctionJan 27, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE ON (B)(6) 2026. AFTER DEFLATION, DIFFICULTY IN REMOVING THE BALLOONS OCCURRED ON BOTH SIDES. DESPITE TRYING TO RESOLVE THE ISSUE, THE BALLOONS COULD NOT BE REMOVED, SO THE SURGEON REMOVED THE WORKING SLEEVE, AND THE BALLOONS WERE CUT AND REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189251 ↗
• MalfunctionJan 26, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED A PERCUTANEOUS VERTEBROPLASTY(T12) FOR VERTEBRAL FRACTURE OCCURRED ON JAN 13, 2026. AFTER DEFLATION, WHEN THE SURGEON TRIED TO REMOVE THE BALLOON, IT BECAME DIFFICULT TO REMOVE THE BALLOON. DESPITE TRYING VARIOUS METHODS, IT WAS NOT POSSIBLE TO REMOVE IT, SO THE WORKING SLEEVE WAS REMOVED AND THE ACCESS NEEDLE WAS REINSERTED, AND THE PROCEDURE HAD TO BE REPEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177346 ↗
• MalfunctionJan 26, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE WAS PERFORMED ON (B)(6) 2026. AFTER DEFLATION, WHEN THE SURGEON TRIED TO REMOVE THE BALLOON, IT BECAME DIFFICULT TO REMOVE THE BALLOON. DESPITE TRYING VARIOUS METHODS, IT WAS NOT POSSIBLE TO REMOVE IT, SO THE WORKING SLEEVE WAS REMOVED AND THE ACCESS NEEDLE WAS REINSERTED, AND THE PROCEDURE HAD TO BE REPEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176886 ↗
• MalfunctionJan 26, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE WAS PERFORMED ON (B)(6) 2026. AFTER DEFLATION, WHEN THE SURGEON TRIED TO REMOVE THE BALLOON, IT BECAME DIFFICULT TO REMOVE THE BALLOON. DESPITE TRYING VARIOUS METHODS, IT WAS NOT POSSIBLE TO REMOVE IT, SO THE WORKING SLEEVE WAS REMOVED AND THE ACCESS NEEDLE WAS REINSERTED, AND THE PROCEDURE HAD TO BE REPEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176879 ↗
• MalfunctionDec 29, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED A VERTEBROPLASTY(L4) WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS PERFORMED ACCORDING TO THE PROCEDURE MANUAL AND THE BALLOON WAS INFLATED. WHEN ATTEMPTING TO EXTRACT THE BALLOON FOR CEMENT INJECTION, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE OUTER TUBE, AND THE SHAFT EVENTUALLY CAME OUT STRETCHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23913563 ↗
• MalfunctionDec 29, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED A VERTEBROPLASTY(L4) WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS PERFORMED ACCORDING TO THE PROCEDURE MANUAL AND THE BALLOON WAS INFLATED. WHEN ATTEMPTING TO EXTRACT THE BALLOON FOR CEMENT INJECTION, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE OUTER TUBE, AND THE SHAFT EVENTUALLY CAME OUTSTRETCHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23913415 ↗
• 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 ↗
• MalfunctionDec 4, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A VERTEBROPLASTY (TH12) PERFORMED ON (B)(6) 2025. THE BALLOON WAS INFLATED ACCORDING TO THE PROCEDURE, BUT WHEN THE SURGEON TRIED TO REMOVE IT, IT WOULDN'T COME OUT. IN THE END, THE SURGEON REMOVED THE WORKING SLEEVE AND THEN THE BALLOON WAS ABLE TO REMOVE, SO THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720243 ↗
• MalfunctionNov 5, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(TH12) PERFORMED ON (B)(6) 2025. DURING SURGERY, WHEN ATTEMPTING TO INSERT THE BALLOON INTO THE BODY, THE BALLOON WOULD NOT PASS THROUGH THE NEEDLE. THE SURGEON TRIED REMOVING THE AIR AGAIN BUT WERE UNABLE TO INSERT THE BALLOON. WHEN THE SURGEON CHECKED THE BALLOON ITSELF, IT WAS FLATTENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478917 ↗

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