OmnicurveRecalls & reported problems across all models

We found 4 models of Omnicurve by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2023 and Sep 15, 2026 — classified as 7 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (34 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 Omnicurve problems

Omnicurve models

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

• Omnicurve 1032-115-000

  Arthroscope
  20 reports
• Omnicurve 1032-120-000

  CEMENT, BONE, VERTEBROPLASTY
  13 reports
• Omnicurve 1032015000

  Arthroscope
  1 report
• Omnicurve 1032020000

  Arthroscope
  1 report

Recent Omnicurve adverse event reports

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

• MalfunctionSep 15, 2026Fracture

  It was reported that the OmniCurve sheath broke off and was left in the patient. There was no medical intervention, no adverse consequences and no clinically significant surgical delay.

  Patient problems: Foreign Body In Patient

  MAUDE report 50779258 ↗
• 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 12, 2026Fracture

  IT WAS REPORTED THAT A PIECE OF THE CANNULA WAS LEFT IN THE PEDICLE OF THE PATIENT. THE PROCEDURE WAS CANCELLED AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25148163 ↗
• 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 18, 2026Fracture

  IT WAS REPORTED THAT THE OMNICURVE INTRODUCER PEAK BROKE OFF WHEN THE PHYSICIAN WAS USING A MALLET ACROSS THE BONE. THE PEAK SHEATH WAS NOT LEFT IN THE PATIENT. THE DEVICE WAS THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630299 ↗
• MalfunctionMar 18, 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 24627018 ↗
• 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 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CONDUIT BROKE AND REMAINED 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 23872299 ↗
• MalfunctionAug 20, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849186 ↗
• MalfunctionAug 13, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22792570 ↗
• 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 ↗

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