Equinoxe 309-10-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862267726), received between Oct 7, 2019 and Apr 5, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT THIS DEVICE WAS DAMAGED. NO OTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684546 ↗
• MalfunctionApr 5, 2023Break; Break

  IT WAS REPORTED THAT THIS DEVICE WAS DAMAGED. NO OTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684500 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED, FRACTURED LOCKING CLIP WAS DAMAGED DURING TRAILING OF DEVICE. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT INFORMATION/MEDICAL HISTORY AVAILABLE. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859523 ↗
• MalfunctionOct 7, 2019Break; Material Twisted/Bent; Noise, Audible

  IT WAS REPORTED THAT THE SURGEON DID A TRIAL REDUCTION UNDER TENSION, HEARD A CRACKING NOISE THEN NOTICED THE TRIAL HAD BENT AT THE JUNCTION OF THE 50MM TRIAL LENGTH AND THE PROXIMAL BODY. THE DISCOVERED THE CENTRAL PEG HAD SNAPPED OFF AND BROKEN. THEN WENT TO TRIAL USING THE DEFINITIVE IMPLANTS INSTEAD. SURGERY PROGRESSED AFTER SLIGHT DELAY. THE PATIENT WAS STABLE WAS THEY LEFT THE OR. THE REP WAS PRESENT AT THE TIME OF THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162324 ↗