MatrixMIDFACE 04.503.324Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587019772), received between Jan 9, 2023 and Jan 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT INTEROPERATIVELY-MAXILLARY REPOSITIONING OSTEOSYNTHESIS WAS PERFORMED IN (B)(6) 2022. METAL REMOVAL WAS PERFORMED ON (B)(6) 2022 DUE TO INSTABILITY OF THE MAXILLA, INTRAOP THE PLATES WERE FOUND TO BE BROKEN AND A NEW OSTEOSYNTHESIS WAS NECESSARY. THE SOFT TISSUE SHOWED A CLEAR BLUE DISCOLOURATION, THE COLOURING OF THE REMOVED PLATES IS BLUE. SURGERY DELAY TIME- MAX.45 MIN. THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATMIDF L-PL 2+3HO R T0.5 TI. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16122111 ↗
• InjuryJan 9, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT INTEROPERATIVELY-MAXILLARY REPOSITIONING OSTEOSYNTHESIS WAS PERFORMED IN (B)(6) 2022. METAL REMOVAL WAS PERFORMED ON (B)(6) 2022 DUE TO INSTABILITY OF THE MAXILLA, INTRAOP THE PLATES WERE FOUND TO BE BROKEN AND A NEW OSTEOSYNTHESIS WAS NECESSARY. THE SOFT TISSUE SHOWED A CLEAR BLUE DISCOLOURATION, THE COLOURING OF THE REMOVED PLATES IS BLUE. SURGERY DELAY TIME- MAX.45 MIN. THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATMIDF L-PL 2+3HO R T0.5 TI. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16122003 ↗

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