NA 239.84Recalls & reported problems
Synthes GmbH · 130 DEG ADULT OSTEOTOMY PLATE 70MM · Class 2 · Implant
- 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 10886982162830), received between Sep 11, 2024 and Sep 11, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2024Break; Break
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 (B)(6) 2000 TO (B)(6) 2023 AT (B)(6). PATIENT NUMBER (B)(6). PATIENT IS A 36 YEARS OLD, MALE . REASON FOR IMPLANTATION WAS OSTEOTOMY. POST OP COMPLICATION INCLUDED HWF - BROKEN BLADE PLATE AND SCREWS. TREATMENT/INTERVENTION INCLUDED REVISION ORIF OF HIP OSTEOTOMY. IMPLANT(S) INVOLVED: 130 DEGREE 70MM BLADE, CORTEX SCREW X4. (B)(4), WHICH WAS CREATED TO CAPTURE THE PATIENT #(B)(6). THIS REPORT IS FOR ONE (1) 130 DEG ADULT OSTEOTOMY PLATE 70MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 20197183 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.