OmniPore Surgical Implant OP7544Recalls & reported problems
Matrix Surgical Holdings, LLC · Design Y™ Mandible Onlay - Medium - Right · Class 2 · Implant
All models of OmniPore Surgical Implant (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855421005673), received between Apr 25, 2024 and Apr 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's identifier.
2 other recalls cover devices cleared under the same FDA submission (K123908); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jan 25, 2017Class IITerminated
Mislabeling. The packaging labeled as left mandible contained a right mandible.
Z-1382-2017 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Discomfort1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ACCORDING TO THE INITIAL REPORT, THE PROSTHESIS BROKE INSIDE THE PATIENT WHEN THE SURGEON WAS FIXINFG IT. THE SURGEON WAS UNABLE TO REPLACE IT WHICH CREATED AESTHETIC IMPERFECTIONS .
Patient problems: Discomfort; Insufficient Information
MAUDE report 19183395 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123908. One submission often covers many models, so check the product and lot details in each record.
- Z-1223-2019 · Jan 30, 2019 · TerminatedOMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
- Z-1224-2019 · Jan 30, 2019 · TerminatedOMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
Other Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction devices
- OmniPore Surgical Implant OP9520Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP9519Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP7543Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall0 reports
- Su-Por Surgical Implants 4353Poriferous, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction8 reports
- OmniPore Surgical Implant OP8330Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction3 reports
- HTR-PEKK PK620905Oxford Performance Materials, Inc. · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2 reports
- OmniPore Surgical Implant OP8322Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2 reports
- SU-POR Surgical Implant 4633Poriferous, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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