NA TEB-2XRecalls & reported problems
Fehling Instruments GmbH & Co. KG · CERAMO CONCEPT X punch flat foot, 40° upw. 2.0x200 mm · Class 2
Data updated Oct 13, 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 04058749086201), received between Nov 28, 2018 and Nov 28, 2018 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2018Break; Detachment of Device or Device Component
IN A (B)(6) HOSPITAL, A PART OF A MANUAL RONGEUR (PUNCH) HAS BROKEN OFF. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. THE PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8110919 ↗
Other Rongeur, Manual devices
- Integra® Miltex® 26-332Integra Lifesciences Production Corporation · RONGEUR, MANUAL3 reports
- Symmetry DECKER 53-4000Aspen Surgical Products, Inc. · Rongeur, Manual3 reports
- Symmetry FERRIS-SMITH 53-1160Aspen Surgical Products, Inc. · Rongeur, Manual2 reports
- Symmetry Rapidclean® 53-1624LDAspen Surgical Products, Inc. · Rongeur, Manual2 reports
- V. Mueller NL4291-81TSteris Corporation · RONGEUR, MANUAL2 reports
- V. Mueller NL6147Steris Corporation · RONGEUR, MANUAL2 reports
- Millennium 85-2481559Avalign Technologies, Inc. · RONGEUR, MANUAL1 report
- Symmetry KERRISON 53-1405Aspen Surgical Products, Inc. · Rongeur, Manual1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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