Omnicurve 1032-115-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327554496), received between Mar 20, 2023 and Aug 12, 2026 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Fracture

  Patient problems: Foreign Body In Patient

  MAUDE report 50226034 ↗
• MalfunctionMay 14, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SHEATH BROKE AND REMAINED IN THE PATIENT. THE SHEATH WAS NOT ABLE TO BE REMOVED. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25172983 ↗
• MalfunctionMay 6, 2026

  DURING THE L3 KYPHOPLASTY PROCEDURE, THE DISTAL PORTION OF THE PEAK SHEATH FROM THE OMNICURVE CURVED NEEDLE FRACTURED AND BECAME EMBEDDED IN THE CEMENT WITHIN THE L3 VERTEBRAL BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25093093 ↗
• MalfunctionApr 16, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SHEATH BROKE AND REMAINED IN THE PATIENT. THE SHEATH WAS NOT ABLE TO BE REMOVED. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24899459 ↗
• MalfunctionApr 7, 2026Fracture

  IT WAS REPORTED THAT AFTER COMPLETING OMNICURVE CASE AND REMOVING INSTRUMENTS THAT SOME DISTAL PORTION OF PEEK SHEATH HAD BROKEN OFF AND WAS LEFT IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24805444 ↗
• MalfunctionMar 10, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SHEATH BROKE AND REMAINED IN THE PATIENT. THE SHEATH WAS NOT ABLE TO BE REMOVED. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24561352 ↗
• MalfunctionJul 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PORTION OF THE PEAK SHEATH WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22472673 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF THE BALLOON MAY HAVE BEEN LEFT IN THE PATIENT AFTER IT RUPTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21710748 ↗
• MalfunctionFeb 25, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460010 ↗
• MalfunctionFeb 20, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21421795 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED THAT THE INTRODUCER BROKE DURING SURGERY. THERE WAS NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786592 ↗
• InjurySep 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE OMNICURVE PEEK SHEATH BECAME STUCK AFTER THE CEMENT WAS INJECTED AND ANOTHER SURGEON WAS CALLED IN TO REMOVE THE DEVICE. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127984 ↗
• MalfunctionJul 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DOCTOR ADVANCED THE OMINCURVE INTO A PATIENT WITH HARD BONE. AFTER GETTING IT INTO THE PROPER POSITION, HE WENT TO REMOVE IT AND IT BECAME DIFFICULT BUT HE WAS ABLE TO GET THE INTRODUCER OUT. WHEN HE EXAMINED IT, HE NOTED A 1CM PIECE OF THE PEEK SHEATH HAD COME OFF AND REMAINED IN THE PATIENT. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT IMPACT, ANY MEDICAL INTERVENTION, A 3 MINUTE SURGICAL DELAY, AND NO ADVERSE CONSEQUENCES.

  Patient problems: Foreign Body In Patient

  MAUDE report 19828180 ↗
• InjuryJul 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE OMNICURVE ACCESS CANNULA SHEARED OFF IN A PATIENT WITH VERY HARD BONE. IT SHEARED OFF AFTER MULTIPLE ATTEMPTS TO REMOVE THE DEVICE FROM THE VERTEBRAL BODY. THE PROCEDURE WAS NOT COMPLETED AND THE PATIENT WAS SENT TO ANOTHER FACILITY DUE TO THE HARD BONE. THE PATIENT HAD AN ADDITIONAL SURGERY BUT THEY WERE NOT SUCCESSFUL IN REMOVING THE PIECE FROM THE VERTEBRAL BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19690999 ↗
• MalfunctionJun 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE OMNICURVE INTRODUCER BROKE TOWARDS THE HANDLE WHILE IN THE VERTEBRAL BODY OF A PATIENT. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT, NO MEDICAL INTERVENTION, NO SURGICAL DELAYS, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546927 ↗
• InjuryApr 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE DOCTOR WAS UNABLE TO REMOVE THE TROCAR FROM THE PATIENT. AFTER MULTIPLE ATTEMPTS THE DEVICE WAS REMOVED IN MULTIPLE PIECES. IT SHOULD BE NOTED THAT THE SURGEON BELIEVES THIS WAS LIKELY DUE TO THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT OR SURGICAL DELAY. THEY WERE ABLE TO REMOVE THE PIECES FROM THE PATIENT SUCCESSFULLY WITH SURGICAL EXPLORATION. NO ADDITIONAL INCISIONS WERE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103977 ↗
• InjuryJan 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PART OF THE DEVICE FROM THE OMNI CURVE BECAME STUCK AND INSIDE THE VERTEBRAL BODY. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT, THE PART BROKE OFF. THE PATIENT HAD A FOLLOW UP WITH AN ORTHOPEDIC DOCTOR TO REMOVE THE PIECE OUTSIDE OF THE VERTEBRAL BODY. THIS FOLLOW UP WAS SUCCESSFUL. IT SHOULD BE NOTED THE AFTER THE FOLLOW UP PROCEDURE, THE PATIENT IS DOING FINE AND IS PAIN FREE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18520367 ↗
• MalfunctionNov 9, 2023Fracture; Fracture

  IT WAS REPORTED PER SALES REP THAT THE OMNICURVE BALLOON KIT SUSTAINED A BREAK IN THE CURVED CONDUIT. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT IMPACT, AND WITHOUT ANY ADVERSE CONSEQUENCES. THERE WAS A 3-5 MINUTE DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099488 ↗
• InjuryOct 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SHEATH FROM THE OMNI CURVE BECAME STUCK AND BROKE OFF DURING RETRACTION. A BIOPSY DEVICE WAS USED TO CUT THE SHEATH AND THE PIECE WAS REMOVED. IT SHOULD BE NOTED THE PROCEDURE WAS SUCCESSFUL WITH NO PATIENT IMPACT, NO CLINICALLY SIGNIFICANT DELAY, OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956188 ↗
• InjuryMar 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SHEATH FROM THE OMNI CURVE BECAME STUCK AND INSIDE THE VERTEBRAL BODY. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT, THE HANDLE SNAPPED. THE PATIENT HAD TO BE TRANSPORTED TO THE HOSPITAL FOR SURGICAL REMOVAL THE NEXT DAY. IT SHOULD BE NOTED THE AFTER THE FOLLOW UP PROCEDURE, THE PATIENT IS DOING FINE AND IS PAIN FREE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16574174 ↗