Python Plate LEFT SD11Recalls & reported problems
Treace Medical Concepts, Inc. · Anatomic Tension Side Plate · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853114006037), received between Sep 8, 2017 and Sep 8, 2017 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2017Break; Break
AFTER AN ORIGINAL BUNION SURGERY ON (B)(6) 2017, WHILE REVIEWING RADIOGRAPHIC IMAGES FROM A ROUTINE POSTOPERATIVE FOLLOW-UP ON (B)(6) 2017, THE SURGEON IDENTIFIED THAT THE PLATE (SD-11) HAD BROKEN. HOWEVER, THE SURGEON INDICATED "OBSERVATION ONLY, NO INTERVENTION" IS REQUIRED AT THIS TIME AS IT IS "LIKELY UNRECOGNIZED NEUROPATHY". THE DEVICE REMAINS IMPLANTED WITH NO REVISION SCHEDULED AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6852314 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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