TiMesh 015-018Recalls & reported problems
Medtronic Ps Medical, Inc. · PLATE 015-018 STRAIGHT 20H 5MM HCD · 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 00643169620230), received between Mar 6, 2025 and Mar 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Seroma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2025Break; Fracture; Break; Fracture
(B)(6) 2025 ARED, CF (FOR, HCP): MEDTRONIC RECEIVED INFORMATION REGARDING A PLATE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE PATIENT WAS LEFT WITH A RIGHT SKULL DEFECT AFTER UNDERGOING "CRANIOTOMY AND HEMATOMA REMOVAL" UNDER GENERAL ANESTHESIA ON (B)(6) 2022, DUE TO TRAUMA MORE THAN 2 YEARS AGO, AND WAS ADMITTED TO HOSPITAL ON (B)(6) 2024, FOR "OPEN CRANIOCEREBRAL INJURY POSTOPERATIVE SKULL DEFECT". AFTER COMPLETING RELEVANT EXAMINATIONS, THE PATIENT UNDERWENT SKULL DEFECT REPAIR ON (B)(6) 2024. AFTER THE OPERATION, THEY RECEIVED SYMPTOMATIC TREATMENT WITH FLUID INFUSION. REEXAMINATION SHOWED A SMALL AMOUNT OF FLUID ACCUMULATION UNDER THE FLAP. THE PATIENT WAS TRANSFERRED TO THE REFERRAL HOSPITAL ON (B)(6) 2024, FOR CONTINUED REHABILITATION TREATMENT. ON (B)(6) 2025, THE TITANIUM STRIP WAS FOUND TO BE FRACTURED. AFTER EVALUATING THE CONDITION, A SECOND SURGERY WILL BE PERFORMED IN THE NEAR FUTURE.
Patient problems: Seroma
MAUDE report 21538722 ↗
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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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