SU-POR Surgical Implant 4012Recalls & reported problems
Poriferous, LLC · Sheet 38mm x 50mm x 1.5mm · 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 00815285020120), received between Mar 13, 2020 and Mar 13, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Infection, Pyrogenic1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 02/26/2020, PHYSICIAN COMMUNICATED SIGNS OF INFECTION WITH IMPLANT AND ADVISED THE PATIENT WILL BE UNDERGOING TREATMENT WITH ANTIBIOTICS. PHYSICIAN COMMUNICATED THAT A SURGERY WILL BE SCHEDULED TO REMOVE AND REPLACE THE INFECTED IMPLANT. ON 02/28/2020, THE PHYSICIAN ADVISED THAT UPON COMPLETION OF THE REVISION SURGERY, IT WAS NOTICED THAT THE INFECTION WAS PRESENT IN THE MAXILLARY SINUS RATHER THAN THE IMPLANT. THE IMPLANT WAS REMOVED AS A PRECAUTION AND REPLACED WITH ANOTHER SU-POR SURGICAL IMPLANT ON (B)(6) 2020.
Patient problems: Infection, Pyrogenic
MAUDE report 9829836 ↗
Other Prosthesis, Chin, Internal devices
- MEDPOR 5444-0-310Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL6 reports
- MEDPOR 5444-0-510Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL4 reports
- MEDPOR 5444-0-410Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL4 reports
- MEDPOR 82007Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL4 reports
- MEDPOR 5444-0-110Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL3 reports
- MEDPOR 5444-4-310Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL3 reports
- Conform™ Extended Anatomical Chin Size: MediumImplantech Associates, Inc. · Prosthesis, Chin, Internal3 reports
- MEDPOR 80010Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL3 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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