Su-Por Surgical Implants 4294Recalls & reported problems
Poriferous, LLC · Ear Wedge Thin - Left - 15mm x 44mm x 11mm · Class 2 · Implant
Data updated Oct 18, 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 00815285022131), received between Jan 15, 2020 and Jan 15, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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.
Most reported problems
Device problems
- Device Appears to Trigger Rejection1
Patient problems
- Pocket Erosion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AN IMPLANT REQUIRED REMOVAL DUE TO EXPOSURE. UPON EXAMINATION OF THE REMOVED IMPLANT, NO SIGNS OF INFECTION WERE PRESENT. THE SURGEON ORDERED A CULTURE OF THE EXPLANTED DEVICE. RESULTS WERE NEGATIVE FOR INFECTION. THE AREA OF TISSUE BREAKDOWN AND EXPOSURE WERE LOCATED IN WHAT THE SURGEON DESCRIBED AS "AREAS OF POTENTIAL PRESSURE NECROSIS". IF THE SURGICAL DRESSING CUP IS DISPLACES, IT IS POSSIBLE FOR THE PRESSURE ON THE EAR TO CAUSE TISSUE BREAKDOWN. ALSO EXPRESSED BY THE SURGEON IS THE DIFFICULTY TO GET THE PATIENT TO FOLLOW POST OPERATIVE INSTRUCTIONS.
Patient problems: Pocket Erosion
MAUDE report 9594282 ↗
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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