MEDPOR 5444-0-610Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · 5444-0-611 Mandible 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252457671), received between Jun 14, 2021 and Oct 24, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378628 ↗InjuryJun 14, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING THE PROCEDURE SURGEON WAS MADE AWARE THE IMPLANT WAS EXPIRED. THE SURGEON CONTINUED WITH IMPLANTING THE IMPLANT ALTHOUGH IT IS OFF LABEL USE. THERE IS NO FURTHER INFORMATION KNOWN AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11994755 ↗
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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