MEDPOR 86010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252088738), received between Aug 15, 2019 and Aug 15, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K922489); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT THE PATIENT EXPERIENCED CHIN EDEMA, PAIN AND INFLAMMATION ONE WEEK FOLLOWING THE PROCEDURE. AS A RESULT, THE PATIENT IS BEING MONITORED WEEKLY AND HAS UNDERGONE A BIOLOGICAL CLEANING AND BACTERIAL SAMPLING. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS AND CLEANS THE AREA REGULARLY AT HOME. NO SERIOUS COMPLICATIONS NOR REVISION SURGERY HAS BEEN REPORTED.

  Patient problems: Edema; Inflammation; Pain

  MAUDE report 8896401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K922489. One submission often covers many models, so check the product and lot details in each record.

• Z-1090-2015 · Dec 17, 2014 · Terminated
  MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are i