InterActive® Complete Surgical Tray ICSTRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 2
- 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 10841307117551), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration Problem” (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.
Most reported problems
Device problems
- Osseointegration Problem1
Patient problems
- Failure of Implant1
- Inflammation1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2021Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Pain
MAUDE report 12503684 ↗
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- V. Mueller CD5-3B-REDCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.