MEDPOR 6317Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Sphere with Enucleation Implant Inserter · Class 2 · Implant
All models of MEDPOR (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252083375), received between May 21, 2025 and May 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Discolored” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT THERE WAS A YELLOW SPOT ON THE SURFACE OF THE DEVICE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061807 ↗
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 5444-0-510Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL4 reports
- MEDPOR 80010Stryker Leibinger GmbH & Co. KG · PROSTHESIS, CHIN, INTERNAL3 reports
- MEDPOR 5444-4-410Stryker 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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