NA 0306621000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613252639794), received between Jul 26, 2022 and Apr 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24954409 ↗
• MalfunctionOct 28, 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399929 ↗
• MalfunctionSep 9, 2025Break; Difficult to Remove

  WE WERE PERFORMING A MULTIPLE LEVEL KYPHOPLASTY ON THE PATIENT. WE WERE WORKING ON THE L1 VERTEBRAE AND AFTER ACCESS WAS GAINED USING THE 11G ACCESS NEEDLE, THE 11G CURETTE WAS INTRODUCED. THE 11G CURETTE IS USED TO DISPLACE SCLEROTIC/CANCELLOUS BONE DURING PERCUTANEOUS BALLOON-ASSISTED VERTEBRAL AUGMENTATION PROCEDURES. THE CURETTE WAS INSERTED, AND THE PHYSICIAN WAS TAPPING THE DEVICE TO DISPLACE THE SCLEROTIC BONE WHEN THE CURETTE BECAME LODGED IN THE BONE. THE DEVICE WAS THEN TWISTED TO TRY AND DISPLACE THE BONE WHEN THE TIP OF THE DEVICE SHEARED OFF AND THE DISTAL PORTION OF THE CURETTE BROKE OFF, LEAVING A PIECE OF THE DEVICE IN THE VERTEBRAL BODY. THE TIP OFF THE CURETTE WAS WEDGED TO FAR WITHIN THE BONE AND NO ATTEMPT TO RETRIEVE IT WAS MADE. THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY IN PLACE AND FILL THE VERTEBRAL BODY WITH CEMENT. THE STRYKER REP [REPRESENTATIVE] WAS PRESENT AND DISCOVERED THE PARTS OF THE METAL ARE MADE OF NITINOL AND MANY OF THE IMPLANTS USED TODAY ARE MADE OF THIS MATERIAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 23004049 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647057 ↗
• MalfunctionApr 21, 2025Fracture; 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 21876615 ↗
• MalfunctionJan 21, 2025Fracture; 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 21201028 ↗
• MalfunctionApr 15, 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: Foreign Body In Patient

  MAUDE report 19113316 ↗
• MalfunctionJan 22, 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: Foreign Body In Patient

  MAUDE report 18556672 ↗
• MalfunctionApr 25, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806635 ↗
• 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 16261782 ↗
• MalfunctionJul 26, 2022Fracture; 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 15107939 ↗