NA 239.53Recalls & reported problems
Synthes GmbH · 120 DEG ADULT OSTEOTOMY PLATE 65MM · Class 2 · Implant
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 10886982162557), received between Sep 11, 2024 and Sep 11, 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
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 64 PATIENTS THAT WERE IMPLANTED WITH ANGLED BLADE PLATES. IMPLANTATION WAS BETWEEN AUGUST 2000 TO JANUARY 2023 AT (B)(6). PATIENT NUMBER (B)(6). PATIENT IS A 20 YEARS OLD, FEMALE. REASON FOR IMPLANTATION WAS OSTEOTOMY. POST-OP COMPLICATION INCLUDED NONUNION OF FEMORAL NECK FRACTURE. TREATMENT/INTERVENTION INCLUDED REPAIR OF NONUNION OF FEMORAL NECK FRACTURE USING A 130 DEGREE 70MM BLADE PLATE. IMPLANT(S) INVOLVED: 120 DEGREE 65MM. CORTEX SCREW X5. (B)(4) IS RELATED TO (B)(4), WHICH WAS CREATED TO CAPTURE THE PATIENT # (B)(6). THIS REPORT IS FOR ONE (1) 120 DEG ADULT OSTEOTOMY PLATE 65MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 20191225 ↗
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
- 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
- CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 32mm 8124-032Advanced Orthopaedic Solutions, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Single Component5 reports
- CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 38mm 8124-038Advanced Orthopaedic Solutions, Inc. · 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 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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