KMEDIC IPN015479Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 24026704289190), received between Jun 8, 2022 and Jun 9, 2022 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Material Separation; Material Separation

  MW#5109515. DURING THE SPINAL PROCEDURE, A PIN CAME OUT OF THE 3MM KERRISON RONGEUR. AN X-RAY WAS PERFORMED TO RULE OUT RETAINED PIN. THE PIN WAS THEN LOCATED OUTSIDE THE PATIENT ON THE STERILE FIELD. STAFF REPORT THAT THIS WAS THE SECOND INSTANCE OF THESE K MEDIC KERRISON RONGEURS LOSING THEIR PINS. STAFF ALSO REPORT THERE WERE INSTANCES OF STICKING OR FREEZING DURING USE WITH THIS INSTRUMENT SET. FDA SAFETY REPORT ID#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644897 ↗
• MalfunctionJun 8, 2022Material Separation; Material Separation

  DURING THE SPINAL PROCEDURE, A PIN CAME OUT OF THE 3MM KERRISON RONGEUR. AN X-RAY WAS PERFORMED TO RULE OUT RETAINED PIN. THE PIN WAS THEN LOCATED OUTSIDE THE PATIENT ON THE STERILE FIELD. STAFF REPORT THAT THIS WAS THE SECOND INSTANCE OF THESE K MEDIC KERRISON RONGEURS LOSING THEIR PINS. STAFF ALSO REPORT THERE WERE INSTANCES OF STICKING OR FREEZING DURING USE WITH THIS INSTRUMENT SET. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633717 ↗