ANTHOLOGY 71356010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010567802), received between Feb 1, 2019 and Dec 14, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT, DURING SET UP OF A THR PROCEDURE, THE FIRST LAYER OF IMPLANT STERILE PACKAGING ON A CORNER WAS LOOSE WHEN THE IMPLANT WAS PULLED FOR CASE. HOSPITAL STAFF OPTED TO NOT USE AN IMPLANT BECAUSE OF THE LOOSE CORNER SEAL. THERE WAS A TECHNIQUE CHANGE, AND THE PROCEDURE WAS FINISHED WITH AN ANTHOLOGY HIGH OFFSET SZ 10. THERE WAS NO DELAY OR FURTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003015 ↗
• MalfunctionFeb 1, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ANTHOLOGY BROACH HANDLE SCREW ON IMPACTOR BROKE OFF IN IMPLANT (WHERE YOU SCREW IT IN). BACKUP DEVICE WAS AVAILABLE AND UNKNOWN IF A DELAY OCCURRED DUE TO THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297226 ↗