PROFYLE 62-10110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540258212), received between Jun 24, 2019 and Jun 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (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.

• MalfunctionJun 24, 2019Incorrect Measurement

  IT WAS REPORTED THAT, AFTER DRILLING, USER MEASURED THE LENGTH WITH DEPTH GAGE AND ATTEMPTED TO INSERT THE FIRST SCREW, BUT THE SCREW WAS TOO LONG. USER THEN SELECTED A SIZE DOWN SCREW, THEN CONTINUED SELECTING UNDER SIZE SCREWS THE SAME WAY AND COMPLETED THE PROCEDURE. THE GAGE MEASUREMENT WAS INCORRECT. NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727047 ↗