MEDPOR TITAN 81033Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Orbital Floor and Wall BTB · Class 2 · Implant
All models of MEDPOR TITAN (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252084341), received between Jun 22, 2018 and Jan 10, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient-Device Incompatibility1
Patient problems
- No Code Available1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT AFTER AN INITIAL SURGERY WAS COMPLETED A REVISION SURGERY TOOK PLACE TO REMOVE AN IMPLANT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THE REVISION SURGERY, WHICH WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY.
Patient problems: No Code Available
MAUDE report 8237067 ↗InjuryJun 22, 2018Patient-Device Incompatibility
IT WAS REPORTED THAT AN ORBITAL FLOOR PLATE HAD TO BE REMOVED BECAUSE THE PATIENT STARTED TO EXPERIENCE DOUBLE VISION FOLLOWING THE SURGERY.
Patient problems: Visual Impairment
MAUDE report 7629641 ↗
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 · TerminatedMEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
- Z-1093-2015 · Dec 17, 2014 · TerminatedMEDPOR 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 · TerminatedMEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications
Other Mesh, surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- SurgiMend® 606-200-020Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-005-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-008Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-200-016Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-021Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-206-007Tei Biosciences Inc. · Mesh, surgical1 recall0 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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