Optetrak Logic 02-012-51-1511Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862230294), received between May 5, 2021 and Jun 22, 2022 — classified as 2 injuries.

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

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJun 22, 2022Naturally Worn; Naturally Worn

  AS REPORTED, FEMALE PATIENT HAD A REMOVED POLY FOR EXCESSIVE WEAR. POLY NOTICED ON X-RAY FOR BEING WORN. PATIENT WAS REVISED TO A NEW POLY. ALL PARTS AND PIECES WERE REMOVED. NONE FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 14781948 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 17 MONTHS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT HAD A REVISION DUE TO INSTABILITY AND THE SURGEON UPSIZED TO 15MM INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE NOT RETURNING, HOSPITAL DISPOSED OF IT.

  Patient problems: Failure of Implant

  MAUDE report 11779301 ↗