MatrixMIDFACE 04.503.203.01Recalls & reported problems
Synthes GmbH · TI MATRIXMIDFACE SCREW SELF-TAPPING 3MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587018720), received between Jan 14, 2020 and Jan 14, 2020 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF CRANIOS REINFORCED FAST SET PUTTY, ONE (1)TITANIUM MATRIXNEURO RECONSTRUCTION MESH, ONE (1) 3MM TITANIUM MATRIX MIDFACE SCREW, ONE (1) 10MM TITANIUM MATRIX MIDFACE SCREW, AND ONE (1) 4MM TITANIUM MATRIX MIDFACE SCREW DUE TO C DIFFICILE INFECTION POSTOPERATIVELY. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2015. THE PATIENT WAS ON A CEPHALEXIN ANTIBIOTIC THERAPY DUE TO COMPLICATION KNOWN ON (B)(6) 2015. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-TAPPING 3MM. THIS IS REPORT 3 OF 5 FOR (B)(4).
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9587494 ↗
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 · TerminatedMatrixMIDFACE 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
Other SCREW, FIXATION, INTRAOSSEOUS devices
- MatrixMIDFACE 04.503.226.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 400.736ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- OsteoMed 204-1206Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS14 reports
- NA 201.928Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS14 reports
- LEVEL ONE CMF 25-092-12-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS11 reports
- OsteoMed 202-2016Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS9 reports
- LEVEL ONE CMF 25-092-08-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS9 reports
- MatrixMIDFACE 04.503.204.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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