NA 62-18330Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540366719), received between Jul 26, 2018 and Jun 25, 2021 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING THE SURGICAL PROCEDURE, THE SPRING ON THE DEVICE BROKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068367 ↗
• MalfunctionMay 6, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING THE SURGICAL PROCEDURE, THE IN-SITU PLATE CUTTER BROKE WHILE CUTTING A PLATE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787520 ↗
• MalfunctionMay 6, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING THE SURGICAL PROCEDURE, THE IN-SITU PLATE CUTTER BROKE WHILE CUTTING A PLATE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787519 ↗
• MalfunctionJan 29, 2021Crack; Crack

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT IT WAS NOTICED DURING THE PROCEDURE, THE DEVICE WAS CRACKED. THERE IS NO OTHER INFORMATION KNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 11253820 ↗
• MalfunctionJan 28, 2021Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE BLADE OF THE DEVICE BROKE DURING THE PROCEDURE. A BACKUP WAS USED TO COMPLETE THE SURGERY. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11246144 ↗
• MalfunctionJan 15, 2021Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT WHILE TRYING TO CUT A HOLE IN THE PLATE, THE TIP OF THE BLADE BROKE OFF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181248 ↗
• MalfunctionJan 11, 2021Fracture; Fracture

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT WHILE TRYING TO CUT A HOLE IN HE PLATE, THE TIP OF THE BLADE BROKE OFF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11151008 ↗
• MalfunctionAug 13, 2020Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE CUTTERS HAVE A CHIP OFF THE TIP OF THE CUTTING BLADE AND THE CUTTERS WILL NOT CLOSE COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10404894 ↗
• MalfunctionJun 9, 2020Fracture; Fracture

  UPON INSPECTION, THE COMPANY REPRESENTATIVE NOTICED THAT THE PLATE CUTTER'S CUTTING BLADES AND TIP ARE BROKEN.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10134827 ↗
• MalfunctionJan 27, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT THE PLATE CUTTERS HAVE CHIPS ON BOTH TIPS AND ALONG THE CUTTING EDGE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9634102 ↗
• MalfunctionJan 10, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT WHEN THE SURGEON WAS USING THE CUTTERS TO CUT THROUGH A PLATE, THE PLATE DID NOT SHEAR AND INSTEAD THE CUTTERS BEGAN STRIPPING AWAY/FRACTURING IN SMALL INCREMENTS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9575534 ↗
• MalfunctionMar 29, 2019Fracture

  IT WAS REPORTED THAT THE IN-SITU CUTTER FRACTURED ON THE RIVET HOLE DURING A CRANIOTOMY CASE. THE CUTTER WAS USED TO CUT 1.7MM PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464852 ↗
• MalfunctionMar 19, 2019Break; Mechanical Problem

  DURING THE PRODUCT QUALITY INVESTIGATION IT WAS FOUND THAT A SMALL FRAGMENT BROKE OUT OF THE UPPER CUTTING EDGE, AND THE SURFACE REVEALS A FRACTURE DUE TO A MECHANICAL OVERLOAD. THIS OCCURRED DURING THE INVESTIGATION, SO THERE WAS NO ASSOCIATED PROCEDURE, AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434364 ↗
• MalfunctionAug 21, 2018Break

  IT WAS REPORTED THAT THE IN-SITU PLATE CUTTER BROKE INTRA-OPERATIVELY, WHILE TRYING TO CUT A PLATE. NO MEDICAL INTERVENTION, DELAY OF SURGERY, OR ADVERSE CONSEQUENCES WERE REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7800795 ↗
• MalfunctionJul 26, 2018Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON WAS CUTTING A PLATE WHEN THE CUTTERS BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7723418 ↗