NA 245.34Recalls & reported problems
Synthes GmbH · 3.5MM CURVED RECONSTRUCTION PLATE 14 HOLES · Class 2 · Implant
Data updated Oct 13, 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 10886982170057), received between May 12, 2025 and May 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration1
Patient problems
- Failure of Implant1
- Pocket Erosion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 22004547 ↗
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT devices
- LCP 241.901Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT33 reports
- CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 36mm 8124-036Advanced Orthopaedic Solutions, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Single Component9 reports
- CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 46mm 8124-046Advanced Orthopaedic Solutions, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Single Component6 reports
- CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 48mm 8124-048Advanced Orthopaedic Solutions, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Single Component6 reports
- CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 38mm 8124-038Advanced Orthopaedic Solutions, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Single Component5 reports
- LCP 241.903Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT5 reports
- CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 44mm 8124-044Advanced Orthopaedic Solutions, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Single Component5 reports
- NA 202.830Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT5 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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