MEDPOR 5444-0-510Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · 5444-0-511 Midface Implant (2) / 5444-0-112 Host Bone (1) · Class 2 · Implant
All models of MEDPOR (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252457657), received between Dec 3, 2021 and Sep 29, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).
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
- Device Appears to Trigger Rejection2
- Adverse Event Without Identified Device or Use Problem1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions1
- Skin Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Appears to Trigger Rejection
It was reported that after implantation of a custom MEDPOR orbital recon implant, an infection was observed requiring a revision surgery.
Patient problems: Unspecified Infection
MAUDE report 50931985 ↗InjurySep 29, 2026Device Appears to Trigger Rejection
It was reported that after implantation of a custom MEDPOR orbital recon implant, an infection was observed requiring a revision surgery.
Patient problems: Unspecified Infection
MAUDE report 50931983 ↗MalfunctionMar 3, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE IMPLANT MODEL DID NOT ACCURATELY REPRESENT THE PATIENT¿S REMAINING BONE, RESULTING IN A TWO-HOUR EXTENSION OF THE CASE DUE TO IMPROPER IMPLANT FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497658 ↗InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A MEDPOR SINGLE STAGE WAS IMPLANTED THE PATIENT WAS TREATED WITH RADIOTHERAPY AND CONTRACTED AN INFECTION THAT LED TO A PLANNED REVISION SURGERY. MEDICAL INTERVENTION AND ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED, BUT THE SURGEON ATTRIBUTED THE INFECTION TO THE RADIOTHERAPY.
Patient problems: Skin Infection; Unspecified Infection
MAUDE report 12925190 ↗
Other PROSTHESIS, CHIN, INTERNAL devices
- MEDPOR 5444-0-310Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL6 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
- MEDPOR 5444-4-410Stryker 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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