SCP® Foot & Ankle Kit 514.303Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024205345), received between May 3, 2019 and May 29, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- Pain2
- Extravasation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGICAL TECH TRIED TO REATTACH THE SLEEVE TO THE STEM WHICH CAUSED THE SLEEVE TO BREAK, RENDERING THE STEM UNABLE TO PUSH THE CONTENTS UP THE CYLINDER. A DIFFERENT KIT WAS OPENED, MIXED AND IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105311 ↗InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 21, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
STUDY PARTICIPANT (B)(6) REVISED SURGERY AT SCP SITE DUE TO PAIN.
Patient problems: Pain
MAUDE report 9356246 ↗InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POTENTIAL FOR EXTRAVASATION INTO ANKLE JOINT POST SCP.
Patient problems: Extravasation
MAUDE report 8579378 ↗
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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