NA 447.051Recalls & reported problems
Synthes GmbH · 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587052618), received between Oct 4, 2019 and Jan 28, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020 THETWO (2) BENDING TEMPLATE HOLES FOR RECONSTRUCTION PLATES, ONE (1) BENDING TEMPLATE FOR MATRIXRIB LOCKING PLATES, ONE (1) SCREWDRIVER BLADE HEXAGONAL SELF RETAIN PLUSDRIVE AND TWO (2) TITANIUM LOCKING PLATE HOLES ADAPTION WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION. THIS IS REPORT 5 OF 5 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639841 ↗MalfunctionJan 28, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020 THE TWO (2) BENDING TEMPLATE HOLES FOR RECONSTRUCTION PLATES, ONE (1) BENDING TEMPLATE FOR MATRIXRIB LOCKING PLATES, ONE (1) SCREWDRIVER BLADE HEXAGONAL SELF RETAIN PLUSDRIVE AND TWO (2) TITANIUM LOCKING PLATE HOLES ADAPTION WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION. THIS IS REPORT 4 OF 5 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9639822 ↗MalfunctionOct 4, 2019Break; Break
IT WAS REPORTED THAT, ON (B)(6) 2019, A TITANIUM (TI) MINI LOCKING PLATE AND A DEPTH GAUGE WERE FOUND BROKEN DURING THE AUDIT OF RETURNED DEVICES AT MILLSTONE FACILITY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION. THIS IS REPORT IS 1 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9156730 ↗
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- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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