Complete Surgical Tray CSTRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841307117537), received between May 14, 2022 and May 14, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
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
- Material Deformation2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2022Material Deformation; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 14403630 ↗InjuryMay 14, 2022Material Deformation; Material Deformation
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS A BROKEN/FRACTURED COMPONENT.
Patient problems: Failure of Implant
MAUDE report 14403625 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.