TiMesh® 016-152Recalls & reported problems
Medtronic Ps Medical, Inc. · PANEL 016-152 CRANIAL MESH 152 X 152MM · Class 2 · Implant
All models of TiMesh (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994284648), received between Apr 10, 2018 and Apr 10, 2018 — classified as 1 injury.
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 problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AFTER IMPLANT OF THE PLATE. IT WAS STATED THE PLATE NEEDED TO BE SHAPED PRIOR TO IMPLANT AND THE SHAPING FACTORY WAS A DOMESTIC PLASTIC FACTORY. THE PLATE WAS EXPLANTED DUE TO THE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7412880 ↗
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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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