OmniPore Surgical Implant OP9519Recalls & reported problems
Matrix Surgical Holdings, LLC · Petite Paranasal - Left · 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
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855421005864), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 malfunction.
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.
Recalls naming this device
- Jan 30, 2019Class IITerminated
Product mislabeling.
Z-1223-2019 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2019, A PHYSICIAN REPORTED TO OUR (B)(4) DISTRIBUTOR THAT A OP9520 PETITE PARANASAL - RIGHT WAS LABELED AS A OP9619 PETITE PARANASAL - LEFT. THE SPECIFIC REPORTED INFORMATION FROM THE DISTRIBUTOR'S EMAIL WAS: "OUR CLIENT CLAIMED THE IMPLANT (REF: OP9519)WAS NOT LABELED CORRECTLY. OP9519 SHALL BE PETITE PARANASAL-LEFT, HOWEVER HE FOUND OP9519 AND OP9520 WERE EXACT SAME FOR PARANASAL RIGHT WHILE OPENED THE STERILIZED PACKAGING".
Patient problems: No Patient Involvement
MAUDE report 8362604 ↗
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-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
- Z-1382-2017 · Jan 25, 2017 · TerminatedOP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Other Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction devices
- OmniPore Surgical Implant OP7544Matrix Surgical Holdings, LLC · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP9520Matrix 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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