MatrixMIDFACE 04.503.307Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587019628), received between Apr 1, 2025 and Apr 1, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K050608); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• InjuryApr 1, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED AS FOLLOWS: ON (B)(6) 2022, PATIENT COMPLAINED OF ¿CHRONIC IRRITATION AND TEAR PRODUCTION FROM MEDIAL LEFT LOWER LID.¿ SETS A PLAN FOR ¿RELEASE OF CICATRICIAL ECTROPION WITH SCAR REVISION¿ AND ¿LEFT LOWER LID SCAR RELEASE ECTROPION FROM PRIOR FACIAL FRACTURE REPAIR. ON (B)(6) 2022, OPERATIVE REPORT ON SURGERY AND CICATRICIAL ECTROPION LEFT MEDIAL EYELID DUE, PER COMPLAINTS OF ¿CHRONIC IRRITATION AND TEAR PRODUCTION FROM MEDIAL LEFT LOWER LID.¿ ON (B)(6) 2022, PATIENT COMPLAINED ABOUT ¿SWELLING AND HOW HER EYE IS LOOKING DURING THIS STAGE IN HER HEALING.¿ ON (B)(6) 2022, PATIENT IS CONCERNED FOR HER SCAR TISSUE, AND SHE FEELS LIKE HER EYES ARE VERY SENSITIVE TO LIGHT AND AIR - AS SHE GETS DRY EYES OFTEN.¿ ON (B)(6) 2022, PATIENT UNDERWENT SURGERY FOR A CHIEF COMPLAINT OF ECTROPION, INVOLVING THE LEFT INFERIOR EYELID. THE ECTROPION IS RECURRING AND ASSOCIATED WITH BLURRED VISION. THE ECTROPION IS SEVERE IN SEVERITY.¿ THE SURGEON CATEGORIZED THE EYE ISSUE AS ¿COSMETIC DISSATISFACTION, EYELIDS¿ PER DIAGNOSIS CODE Z41.1, A PROCEDURE FOR PURPOSES OTHER THAN REMEDYING A HEALTH STATE. ¿SCAR WAS REALIGNED ALONG NORMAL ANATOMIC BOUNDARIES¿ DURIN

  Patient problems: Deformity/ Disfigurement; Pain; Visual Disturbances

  MAUDE report 21742892 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050608. One submission often covers many models, so check the product and lot details in each record.

• Z-2739-2020 · Jun 16, 2020 · Terminated
  MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive proced