SU-POR Surgical Implant 4633Recalls & reported problems
Poriferous, LLC · Su-Por Ear 4633 - Right - 36mm x 53mm x 28mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815285024111), received between Mar 7, 2025 and Feb 4, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Expulsion” (1 report).
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Expulsion1
- Improper or Incorrect Procedure or Method1
Patient problems
- Skin Erosion2
- Necrosis1
- Pocket Erosion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
SURGEON REPORTED EXPOSURE OF IMPLANT REQUIRING SURGICAL INTERVENTION.
Patient problems: Pocket Erosion; Skin Erosion
MAUDE report 24261660 ↗InjuryMar 7, 2025Improper or Incorrect Procedure or Method; Expulsion; Improper or Incorrect Procedure or Method; Expulsion
ON (B)(6) 2025, A SURGEON REPORTED AN EXPLANTATION OF AN IMPLANT DUE TO FLAP NECROSIS RESULTING IN IMPLANT EXTRUSION. THE SURGEON REPORTED A NONCOMPLIANT PATIENT AND STATED THE PATIENT WAS NOT FOLLOWING POSTOPERATIVE INSTRUCTIONS FOR PROTECTION. THE IMPLANT WAS REMOVED WITHOUT ANY FURTHER COMPLICATION.
Patient problems: Necrosis; Skin Erosion
MAUDE report 21552234 ↗
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 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
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
- 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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