MEDPOR TITAN 81029Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252084303), received between Feb 15, 2019 and Feb 15, 2019 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K040364); 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 18, 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.

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

  IT WAS REPORTED THAT THREE IMPLANTS WERE EXPLANTED DUE TO SOFT TISSUE COMPLICATIONS. ADDITIONALLY, THE PATIENT HAD ACQUIRED AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8343213 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040364. One submission often covers many models, so check the product and lot details in each record.

• Z-0715-2022 · Dec 29, 2021 · Terminated
  MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
• Z-1093-2015 · Dec 17, 2014 · Terminated
  MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-
• Z-0922-2012 · Dec 16, 2011 · Terminated
  MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications