nexis® SC020032Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700879501215), received between Aug 25, 2025 and Aug 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Migration; Migration

  INITIAL INFORMATION: ANSM (FRENCH COMPETENT AUTHORITY) REPORT FROM THE USER INDICATING A BROKEN SCREW. ADDITIONAL INFORMATION ON AUGUST 6TH: DURING IMPLANTATION IN FEBRUARY, SLIGHT METAL FILINGS CAME LOOSE FROM THE DISTAL THREAD OF THE SCREW. THIS PART REMAINED IN THE SOFT TISSUE SURROUNDING THE BONE. FOUR MONTHS LATER, AS THE PATIENT EXPERIENCED PAIN AND DISCOMFORT, X-RAYS WERE PERFORMED, SHOWING THAT THE FRAGMENT HAD MIGRATED IN THE SOFT TISSUE. THE SURGEON DECIDED TO RE-OPEN THE PATIENT SO AS TO REMOVE THE THREAD. THIS CORRECTION SURGERY WAS PERFORMED ON (B)(6), 2025. THE XRAYS SHOW A DEEP INSERTION OF THE SCREW, SO MUCH THAT IT SEEMS TO PROTRUDE AT LEAST 3MM FROM THE BONE. NB: INCIDENT REPORTED TO ANSM BY THE USER. REF # (B)(4). A SECOND REPORT HAS BEEN ADDRESSED TO ANSM BY THE USER: # (B)(6). IT MENTIONS THE SECOND SCREW USED AT THE SAME TIME BUT IT TURNED OUT TO BE IRRELEVANT AS THIS SECOND SCREW WASN'T PROBLEMATIC.

  Patient problems: Local Reaction

  MAUDE report 22883708 ↗