N/A 9560548Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00673978085982), received between Mar 9, 2021 and Jan 30, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR DISC HERNIATION. PROCEDURE PERFORMED WAS MED. IT WAS REPORTED THAT THE PORTION WITH A CHANGEABLE HOLE FROM THE HANDLE TO THE SHAFT WAS BROKEN AT THE ANCHORING POINT. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273464 ↗
• MalfunctionJan 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT THE CURETTE WAS BROKEN DURING DECOMPRESSION. ANOTHER CURETTE WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21237100 ↗
• MalfunctionApr 8, 2021Break; Break

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633226 ↗
• MalfunctionMar 23, 2021Break; Break

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548678 ↗
• MalfunctionMar 9, 2021Break; Break

  MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441396 ↗