centrolock® PL070204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700879511849), received between Sep 25, 2020 and Dec 31, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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 31, 2025Material Separation; Material Separation

  THIS EVENT TOOK PLACE IN FRANCE, NOVASTEP HAVE BEEN INFORMED OF THIS CASE ON THE 11/25/2025. BREAKAGE OF THE IMPLANT POST OP. DEVICE IMPLANTED ON (B)(6) 2025. AT 6 MONTHS POST IMPLANTATION, ON (B)(6) 2025, A DEVICE PROBLEM WAS SUSPECTED DURING A SCANNER PERFORMED AS THE PATIENT REPORTED UNUSUAL PAIN. THE PROBLEM WAS CONFIRMED ON (B)(6) 2025 BY PERFORMING X-RAYS. IT REVEALS THAT THE IMPLANT HAS BROKEN. CONSEQUENCE: AS REPORTED BY THE SURGEON "AS FAR AS TREATMENT IS CONCERNED, IT REMAINS RELATIVELY PAINLESS FOR THE MOMENT AND BONE CALLUS IS GRADUALLY FORMING AT THE OSTEOTOMY SITE WITH GOOD CORRECTION OF THE FOOT." THE SURGEON HAS THEREFORE AUTHORIZED HER TO GRADUALLY RESUME WEARING NORMAL SHOES WITH RIGID SOLES. HE PLANS TO MONITOR THE PATIENT IN (B)(6) 2026.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 23932540 ↗
• InjurySep 25, 2020Patient Device Interaction Problem

  INITIAL INFORMATION RETRIEVED BY PHONE ON THE 23TH OF JUNE 2020. ADDITIONAL INFORMATION HEREAFTER, DATED OF THE (B)(6) 2020 : « IMPLANT BROKE POST OPERATIVELY. PATIENT WORKS CONSTRUCTION & RETURNED TO NORMAL ACTIVITY SOONER THAN ADVISED BY THE PHYSICIAN. PATIENT SAID HE HEARD THE IMPLANT BREAK AS HE WAS ON THE JOB ». TRACEABILITY DATA RETRIEVED ON THE (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10586212 ↗