Python Plate RIGHT SD12Recalls & reported problems
Treace Medical Concepts, Inc. · Anatomic Tension Side Plate · Class 2 · Implant
Data updated Oct 18, 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 00853114006044), received between Jan 10, 2019 and Jan 10, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2019Break; Break
AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2018, ONE PLATE (SD12) WAS FOUND BROKEN UPON REVIEW OF RADIOGRAPHIC IMAGES FROM THE PATIENT'S POSTOPERATIVE FOLLOW-UP. ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2018 AS A RESULT AND THE PATIENT WAS REVISED WITH NON-TMC HARDWARE. THERE WAS NO OTHER REPORT OF ANY PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Code Available
MAUDE report 8233349 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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