SCP® Foot & Ankle Kit 514.315Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024205352), received between May 20, 2019 and Oct 14, 2020 — classified as 8 injuries.
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
- Adverse Event Without Identified Device or Use Problem7
- Appropriate Device Problem Term/Code Not Available1
- No Apparent Adverse Event1
Patient problems
- Pain6
- No Code Available2
- Bone Fracture(s)1
- Impaired Healing1
- Inflammation1
- Reaction1
- Seizures1
- Weakness1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.
Patient problems: Impaired Healing; Wound Dehiscence
MAUDE report 10677200 ↗InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Reaction; Seizures; Weakness
MAUDE report 10566454 ↗InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADVERSE EVENT FOR SCP FOOT & ANKLE STUDY FOR SUBJECT 12-009
Patient problems: No Code Available
MAUDE report 9498382 ↗InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL STUDY SUBJECT 02-003 EXPERIENCED INCREASED PAIN POST SCP
Patient problems: Pain
MAUDE report 8842416 ↗InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL SUBJECT: (B)(6) EXPERIENCED POST-OPERATIVE PAIN.
Patient problems: Pain
MAUDE report 8842104 ↗InjuryJun 13, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CLINICAL SUBJECT (B)(6) EXPERIENCED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 8697900 ↗InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CLINICAL STUDY SUBJECT (B)(6) EXPERIENCED INCREASED PAIN AFTER SCP.
Patient problems: Bone Fracture(s); No Code Available; Pain
MAUDE report 8625485 ↗
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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