iVAS 0306330000Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07613252505990), received between Jun 15, 2018 and Aug 24, 2026 — classified as 12 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Fracture” (30 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Fracture

  It was reported that the cannula broke inside the the patient, the case was stopped and the canula was removed the following day.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50411877 ↗
• MalfunctionMay 12, 2026Fracture

  IT WAS REPORTED THAT A PIECE OF THE CANNULA WAS LEFT IN THE PEDICLE OF THE PATIENT, WHICH WAS CONFIRMED VIA X-RAY. THE PROCEDURE WAS INTENDED TO COMPLETE BOTH SIDES; HOWEVER, THE SECOND SIDE WASN'T COMPLETED. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25148059 ↗
• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24953814 ↗
• InjuryFeb 27, 2026Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471814 ↗
• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31, 2025. THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD CODE NOT FOUND.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163103 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23368320 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 6 EVENTS FOR THE FAILURE: FRACTURE. 6 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22647061 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21878601 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. TWO EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21201191 ↗
• MalfunctionOct 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DURING THE PROCEDURE, THE ACCESS CANNULA BROKE WHEN IT WAS BEING REMOVED. PER A CT SCAN, IT BROKE OFF FLUSH WITH THE VERTEBRAL PEDICLE. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS A 20 MINUTE DELAY REPORTED AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20408301 ↗
• InjurySep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE 11G ACCESS CANNULA BENT AND CONSEQUENTLY BROKE WHILE BEING REMOVED FROM VERTEBRAL BODY. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT IMPACT, OR MEDICAL INTERVENTION. THERE WAS A SURGICAL DELAY OF 2 HOURS TO REMOVE THE BROKEN DEVICE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136898 ↗
• InjuryAug 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE NEEDLE BROKE DURING USE AND THE TIP OF THE DEVICE REMAINED IN THE PATIENT'S BONE AND COULD NOT BE REMOVED. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 2 HOUR DELAY TO TRY AND REMOVE THE BROKEN PIECE AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20019508 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818342 ↗
• InjuryJun 13, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE INCIDENT OCCURRED DURING THE PROCEDURE WHEN THE TROCAR WAS INTRODUCED INTO THE PATIENT'S PEDICLE. WHEN HE TRIED TO REMOVE THE TROCAR, IT BROKE AT BONE LEVEL BUT WAS ABLE TO BE EXTRACTED BY THE DOCTOR. IT SHOULD BE NOTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITHOUT ANY ADVERSE CONSEQUENCES. THERE WAS A 60 MINUTE DELAY IN THE PROCEDURE DUE TO THE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528702 ↗
• InjuryMay 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF AND WAS STUCK IN THE PATIENT. THE NEEDLE WAS NOT ABLE TO BE REMOVED EITHER. THE PATIENT WAS SUBJECTED TO A LONGER SURGERY AS WELL AS A LARGER INCISION THAN WHAT WAS PLANNED. WE DID INQUIRE ABOUT THE SURGICAL DELAY BUT THE CUSTOMER DID NOT CLARIFY HOW LONG THE DELAY WAS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19220893 ↗
• InjuryApr 9, 2024Fracture; Fracture

  THE DOCTOR REPORTED THAT DURING THE PROCEDURE, THE OUTER CANNULA RIPPED OFF IN THE BONE. IT TOOK ABOUT 2 HOURS TO PROGRESSIVELY DRILL OVER IT AND REMOVE THE OUTER TABLE OF THE ILIAC BONE TO REMOVE IT. IT SHOULD BE NOTED THE PROCEDURE WAS DEEMED SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070372 ↗
• MalfunctionOct 24, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994383 ↗
• MalfunctionApr 24, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801678 ↗
• MalfunctionJan 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261951 ↗
• MalfunctionJan 29, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16261868 ↗
• MalfunctionOct 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666905 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101964 ↗
• MalfunctionMar 14, 2022Fracture; Fracture

  PER THE CUSTOMER, THE OUTER PART OF THE ACCESS CANNULA POPPED OFF THE HUB OF THE NEEDLE. THE DOCTOR WAS REPORTED TO BE EXPOSED TO THE PATIENT'S BLOOD DURING THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757068 ↗
• InjuryFeb 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE/CANNULA BROKE OFF IN THE PATIENT AND THE CASE WAS NOT COMPLETED. MEDICAL INTERVENTION WAS NECESSARY BY ENLARGING THE PEDICLE HOLE TO REMOVE THE DEVICE MATERIAL LEFT BEHIND. A SURGICAL PROLONGATION WAS REPORTED. UPON FOLLOW UP, IT WAS REPORTED THAT THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING WELL AND NO ADDITIONAL PROCEDURE IS PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549554 ↗
• MalfunctionJan 19, 2022Difficult to Remove; Difficult to Remove

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS DIFFICULT TO REMOVE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289816 ↗