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Infinity KBR178Recalls & reported problems

Conmed Corporation · Infinity Anteromedial Guide Right 7/8mm · Class 1

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 30845854902312), received between Sep 1, 2021 and Sep 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 1, 2021Material Fragmentation; Material Fragmentation

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, KBR178, WAS BEING USED ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE AND THE ¿THE UNIT JUST COMES APART WHERE THE TWO PIECES ARE CONNECTED.¿ THERE WAS NO INJURY/IMPACT TO THE PATIENT. AFTER FURTHER ASSESSMENT, IT WAS FOUND THAT THE FRAGMENTS DID FALL INTO THE SURGICAL SITE AND WERE RETRIEVED WITH A GRASPER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12411199 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.