NA M-4DC-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845384013075), received between Feb 7, 2023 and Feb 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

39 other recalls cover devices cleared under the same FDA submission (K113476); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 7, 2023Material Fragmentation; Vibration; Noise, Audible; Material Fragmentation; Vibration; Noise, Audible

  THIS IS REPORT 3 OF 3 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY FOR CERVICAL SPONDYLOSIS, IT WAS DISCOVERED THAT THE MOTOR DEVICE, ATTACHMENT DEVICE AND CUTTER DEVICE MADE NOISE AND HAD VIBRATION. IT WAS FURTHER REPORTED THAT IRON POWDER WAS NOTICED ON THE GLOVE. ACCORDING TO THE REPORTER, A STAFF SET THE DEVICES UNDER THE INSTRUCTION OF THE SURGEON. AFTER SETTING, WHEN THE SURGEON STEPPED ON A PEDAL, NOISE OCCURRED, AND THE SURGEON NOTICED IRON POWDER HAD ADHERED TO THE LEFT GLOVE. IT WAS FURTHER REPORTED THAT NOISE OCCURRED, BUT THE VIBRATION OF THE DEVICES WAS THE SAME AS BEFORE/USUAL. THE REPORTER STATED THAT IT WAS UNKNOWN WHERE THE IRON POWDER CAME FROM. THE REPORTER INDICATED THAT SINCE THE DEVICES WERE BEFORE USE ON THE PATIENT, THE SURGEON STOPPED USING THE DEVICES AND USED OTHER DRILL SYSTEMS TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS TEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310841 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113476. One submission often covers many models, so check the product and lot details in each record.

• Z-2840-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
• Z-2838-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
• Z-2281-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium.
• Z-2285-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2309-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.
• Z-2282-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
• Z-2299-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.
• Z-2280-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2288-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
• Z-2311-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
• Z-2301-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium.
• Z-2306-2015 · Apr 13, 2015 · Terminated
  ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
• Z-2291-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.

…and 24 more.