NA 03.804.612SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034810881), received between Apr 5, 2022 and Mar 16, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY (TH12) PERFORMED ON (B)(6) 2026. THE TROCAR ACCESS KIT WAS DEFECTIVE. THERE WAS RESISTANCE WHILE REMOVING THE PLUNGER FROM THE BARREL AND NOT ABLE TO BE ATTACHED AND DETACHED SMOOTHLY. SO, THE DEVICE IN QUESTION WAS NOT USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603859 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A BKP PERFORMED ON (B)(6) 2026. WHEN THE SURGEON TRIED TO INSERT THE PLUNGER INTO THE SLEEVE, IT STOPPED HALFWAY AND WOULD NOT GO IN. THE SURGEON DECIDED TO OPEN A NEW ONE, THE SLEEVE WAS REPLACED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401661 ↗
• MalfunctionDec 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS PERCUTANEOUS VERTEBROPLASTY(TH12) FOR VERTEBRAL FRACTURE ON (B)(6) 2025. WHILE FOLLOWING SAFETY PROCEDURES AND FOLLOWING SAFETY CHECKS, THE SURGEON FELT A STRONG RESISTANCE WHEN INSERTING THE HOLLOW ACCESS NEEDLE OVER THE GUIDEWIRE AND ATTEMPTING TO REMOVE THE HOLLOW TROCAR AFTER REACHING THE CORRECT POSITION. APPLYING TOO MUCH FORCE DURING REMOVAL COULD HAVE HAD A SIGNIFICANT IMPACT ON THE PATIENT'S VERTEBRAE, POTENTIALLY RESULTING IN A SECONDARY FRACTURE. THEREFORE, THE SURGEON WAS FORCED TO IMMEDIATELY HALT THE PROCEDURE, AND A NEW 03-804-612S ACCESS KIT WAS OPENED AND USED, WHICH WAS AVAILABLE AS A BACKUP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE DEVICE WAS INSPECTED AND THE HOLLOW TROCAR WAS UNABLE TO BE REMOVED FROM THE ACCESS NEEDLE. SINCE NO SPECIAL PROCEDURES WERE PERFORMED AND THE PROCEDURE PROCEEDED SMOOTHLY AFTER THE REPLACEMENT, IT WAS BELIEVED THIS WAS DUE TO THE PRODUCT, BUT THE CAUSE COULD NOT BE CONFIRMED ON-SITE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708308 ↗
• MalfunctionMar 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 22-FEBRUARY-2024 A PERCUTANEOUS VERTEBROPLASTY WAS PERFORMED. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE CONNECTION BETWEEN THE WORKING SLEEVE AND THE TROCAR/CEMENT NEEDLE OF THE ACCESS KIT IN QUESTION WAS LESS THAN USUAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT STATUS IS STABLE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ACCESS KIT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18878158 ↗
• MalfunctionDec 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A VERTEBRAL BODY STENTING PROCEDURE, IT WAS NOT POSSIBLE TO PUSH THE VBS PLACED NOT INFLATED THROUGH THE CANNULA. EITHER THE VBS WAS TOO BIG OR THE ACCESS CANNULA WAS TOO SLIM. THE STEP WAS ATTEMPTED WITH SEVERAL STENTS AND A TOTAL OF FOUR WERE USED. THE SURGEONS ENDED UP SUCCESSFULLY PLACING THE VBS STENT, INFLATING IT, AND PLACING THE CEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT IMPACT. THIS REPORT IS FOR AN ACCESS KIT-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990365 ↗
• InjuryAug 23, 2022Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING PERCUTANEOUS VERTEBROPLASTY (L3) FOR TREATING CENTRUM FRACTURE, IT TOOK 15 MINUTES FOR CEMENT PREPARATION. THE CEMENT WAS NOT EASILY INJECTED WITH A 2MM SYRINGE, SO IT WAS EXCHANGED FOR A 1MM SYRINGE. WHEN THE 2MM OF CEMENT WAS APPLIED TO EACH SIDE, THE CEMENT BECAME HARDER. AS A RESULT, A CEMENT NEEDLE GOT STUCK TO THE CEMENT AND BECAME IMMOVABLE. THE SURGEON DECIDED TO LEAVE THE NEEDLE IN THE LESION, THE PROCEDURE WAS DELAYED BY MORE THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ACCESS KIT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15274501 ↗
• MalfunctionAug 3, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A PERCUTANEOUS VERTEBROPLASTY (L2) WAS PERFORMED FOR TREATING L2 BURST FRACTURE. WHILE FILLING A SYRINGE WITH CEMENT, A NOISE CAME FROM THE HANDLE. APPROXIMATELY 11 MINUTES AFTER STARTING TO INJECT CEMENT INTO THE STENT, THE INJECTION WAS TOUGH TO CONTINUE WITH A 2 ML SYRINGE, SO THEY EXCHANGED IT FOR A 1 ML SYRINGE, BUT THE CEMENT NEEDLE DID NOT REACH THE STARTING MARKER. 0.1 TO 0.2 ML OF CEMENT WAS INJECTED TO BOTH SIDES, BUT THE SURGEON WAS UNABLE TO REMOVE THE NEEDLE ON THE RIGHT SIDE. THE SURGEON CUT OFF SOME DEVICES, LEAVING A WORKING SLEEVE AND 2 TO 3 CM LENGTH OF THE NEEDLE FRAGMENT STUCK TO THE STENT, AND CLOSED THE INCISION. THE PROCEDURE WAS DELAYED BY 40 MINUTES. THE SURGEON NOTED THAT THE PROCEDURE FOLLOWED THE SURGICAL TECHNIQUE, AND THAT THE CEMENT MATERIALS WERE NOT KEPT IN THE CUSTODY OF A REFRIGERATOR. THEY HAD BEEN STORED AT ROOM TEMPERATURE IN THE HOSPITAL¿S BASEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ACCESS KIT-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155886 ↗
• MalfunctionMay 9, 2022Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A PERCUTANEOUS VERTEBROPLASTY (T12) PROCEDURE FOR TREATING T12 COMPRESSION FRACTURE OCCURRED ON (B)(6) 2022. AFTER MAKING SURE THAT CEMENT HAD BECOME HARDENED, THE SURGEON MOVED ON TO REMOVING A CEMENT NEEDLE. HOWEVER, HE HAD DIFFICULTY IN REMOVING THE NEEDLE SMOOTHLY FROM THE PATIENT¿S BODY. WHEN HE FINALLY MANAGED TO PULL OUT THE NEEDLE, A FOREIGN SUBSTANCE HAD STUCK WITH THE TIP OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT WAS POSTOPERATIVELY X-RAYED, AND THE SURGEON CONFIRMED THE SATISFACTORY CEMENT APPLICATION AND NO HARM TO THE PATIENT. THE SURGEON COMMENTED THE FOLLOWING: HE PULLED THE CEMENT NEEDLE OUT UP TO THE BEGINNING MARKER WHILE THE CEMENT WAS HARDENING. THEREFORE, IT IS UNLIKELY THAT THE CEMENT NEEDLE BECAME HARDENED TOGETHER WITH THE CEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN ACCESS KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336280 ↗
• MalfunctionApr 5, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY (L4) FOR TREATING LUMBAR SPINE COMPRESSION FRACTURE ON (B)(6) 2022. AT FIRST, CEMENT WAS APPLIED AT L4 LEFT. WHILE CEMENT ON THE RIGHT WAS BEING INJECTED, THE NEEDLE ON THE LEFT AND THE LEFT CEMENT BECAME HARDENED. AS SOME TROUBLESHOOTING DID NOT WORK, THEY FINALLY ENLARGED THE INCISION AND REMOVED THE NEEDLE AND CUT OFF THE SLEEVE. THE PROCEDURE WAS DELAYED FOR 35 MINUTES. THE SURGEON COMMENTED AS FOLLOWS: THE NEEDLE STAYED IN THE LESION LONGER THAN SUPPOSED TO BE WHICH ALLOWED THE CEMENT TO BECOME HARDENED. THE NURSE WAS NOT SO EXPERIENCED IN MIXING UP THE CEMENT. THE SALES REP IS SUPPOSED TO FIND OUT WHETHER ANY FRAGMENT HAS BEEN LEFT IN THE LESION. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE ACCESS KIT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015391 ↗