PROFILE 230425Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705010479), received between Nov 18, 2025 and Nov 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

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.

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.

• MalfunctionNov 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 2X PROFILE INTSCR 8X25MM PACKAGES LISTED THE PRODUCTION DATE OF THE DEVICE AS (2022), STATED A 3-YEAR EXPIRATION DATE, AND STATED A USE-BY DATE OF 2027-08-31. THE PHYSICIAN FELT THERE WAS A DISCREPANCY. THE PHYSICIAN FELT THAT EITHER THE EXPIRATION DATE IS INCORRECT (IT SHOULD BE 5 YEARS), OR THE SCREWS ARE ALREADY EXPIRED. IT WAS REPORTED THAT THE DEVICES WERE NOT USED IN A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583193 ↗
• MalfunctionNov 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 2X PROFILE INTSCR 8X25MM PACKAGES LISTED THE PRODUCTION DATE OF THE DEVICE AS (2022), STATED A 3-YEAR EXPIRATION DATE, AND STATED A USE-BY DATE OF 2027-08-31. THE PHYSICIAN FELT THERE WAS A DISCREPANCY. THE PHYSICIAN FELT THAT EITHER THE EXPIRATION DATE IS INCORRECT (IT SHOULD BE 5 YEARS), OR THE SCREWS ARE ALREADY EXPIRED. IT WAS REPORTED THAT THE DEVICES WERE NOT USED IN A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583188 ↗