TiMesh 016-200Recalls & reported problems
Medtronic Ps Medical, Inc. · PANEL 016-200 CRANIAL MESH 200 X 200MM · Class 2 · Implant
All models of TiMesh (15)
Data updated Oct 16, 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 00643169620650), received between Dec 5, 2024 and Dec 5, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A CRANIAL MESH FOR A SKULL DEFECT REPAIR. IT WAS REPORTED THAT ONE YEAR AGO, THE PATIENT'S LEFT FOREHEAD SURGICAL INCISION SHOWED INCISION DEHISCENCE, THE TITANIUM PLATE WAS SLIGHTLY EXPOSED, AND THE SKIN NUTRITION WAS POOR. AFTER CONTACTING THE HOSPITAL, SURGERY WAS RECOMMENDED TO REMOVE THE TITANIUM PLATE. AFTER CAREFUL CONSIDERATION, THE FAMILY REQUESTED CONSERVATIVE TREATMENT. AFTER TREATMENT, THE PATIENT'S CONDITION PROGRESSIVELY WORSENED AND THE EXPOSURE AREA OF THE LEFT FRONTAL TITANIUM PLATE PROGRESSIVELY EXPANDED. THE PATIENT HAD BEEN TAKING ENALAPRIL 10MG ORALLY FOR A LONG TIME, ABOUT 12 YEARS AGO. THE PATIENT UNDERWENT INTRACEREBRAL HEMATOMA REMOVAL AND DECOMPRESSIVE CRANIECTOMY, AND HAD A HISTORY OF SECONDARY EPILEPSY. RECENTLY, THE PATIENT HAD TAKEN LEVETIRACETAM TABLETS 0.25 ONCE A NIGHT. UNDER GENERAL ANESTHESIA, SKULL METAL PLATE REMOVAL, EPIDURAL ABSCESS EXCISION AND SKIN DEFECT REPAIR WERE PERFORMED. THE OPERATION WENT SMOOTHLY. AFTER THE OPERATION, ECG MONITORING, OXYGEN INHALATION, NEBULIZATION, AS WELL AS HEMOSTASIS, ANTI-INFLAMMATORY AND FLUID REPLACEMENT WERE GIVEN, SO AS TO INCREASE ENTERAL NUTRITION, AND REGULAR DRES
Patient problems: Wound Dehiscence
MAUDE report 20852311 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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