NA 242.08Recalls & reported problems
Synthes GmbH · QUARTER-TUBULAR PLATE WITH COLLAR 8 HOLES/63MM · 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 10886982167897), received between May 22, 2022 and May 22, 2022 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REMOVAL OF ANKLE PLATES AND HARDWARE OCCURRED. THE SHAFT REMAINED IN THE PATIENT AND THE BROKEN HEAD WAS REMOVED FROM THE PATIENT. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR (1) QUARTER-TUBULAR PL COLLAR 8 HOLES/63. THIS IS REPORT 4 OF 11 FOR COMPLAINT (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14467174 ↗
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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