NA L-8NS-M-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384012511), received between Apr 17, 2019 and Apr 17, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

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 18, 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.

• InjuryApr 17, 2019Overheating of Device; Overheating of Device

  THIS IS REPORT 2 OF 4 FOR THE SAME EVENT: IT WAS REPORTED BY THE SURGEON THAT DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR DEVICE STARTED HEATING UP WHILE BEING USED TOGETHER WITH THE ATTACHMENT AND CUTTER DEVICE. ACCORDING TO THE SURGEON, THE STAFF REPLACED THE FIRST CUTTER DEVICE WITH A SECOND SIMILAR CUTTER. IT WAS FURTHER REPORTED THAT THE MOTOR DEVICE STOPPED AND WAS REPLACED WITH A SECOND SIMILAR DEVICE. THE PROCEDURE CONTINUED. THE SURGEON STATED THAT IT WAS DETERMINED LATER IN THE CASE THAT THE PATIENT RECEIVED A BURN AT THE WOUND SITE, SUGGESTING THE MOTOR DEVICE HEATING UP MAY HAVE CAUSED THE EVENT. IT WAS REPORTED THAT THE SURGEON DID USE ELECTRO CAUTERY ON HIS PROCEDURES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THERE WAS NO ADDITIONAL TREATMENT PERFORMED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AS PLANNED. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WAS NO PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITT

  Patient problems: Burn(s)

  MAUDE report 8522596 ↗
• InjuryApr 17, 2019Overheating of Device; Overheating of Device

  THIS IS REPORT 3 OF 4 FOR THE SAME EVENT: IT WAS REPORTED BY THE SURGEON THAT DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR DEVICE STARTED HEATING UP WHILE BEING USED TOGETHER WITH THE ATTACHMENT AND CUTTER DEVICE. ACCORDING TO THE SURGEON, THE STAFF REPLACED THE FIRST CUTTER DEVICE WITH A SECOND SIMILAR CUTTER. IT WAS FURTHER REPORTED THAT THE MOTOR DEVICE STOPPED AND WAS REPLACED WITH A SECOND SIMILAR DEVICE. THE PROCEDURE CONTINUED. THE SURGEON STATED THAT IT WAS DETERMINED LATER IN THE CASE THAT THE PATIENT RECEIVED A BURN AT THE WOUND SITE, SUGGESTING THE MOTOR DEVICE HEATING UP MAY HAVE CAUSED THE EVENT. IT WAS REPORTED THAT THE SURGEON DID USE ELECTRO CAUTERY ON HIS PROCEDURES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THERE WAS NO ADDITIONAL TREATMENT PERFORMED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AS PLANNED. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WAS NO PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITT

  Patient problems: Burn(s)

  MAUDE report 8522592 ↗

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-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
• 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-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; 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-2296-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
• Z-2292-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-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-2287-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-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-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-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.
• Z-2313-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.
• Z-2298-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
• Z-2305-2015 · Apr 13, 2015 · Terminated
  ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
• Z-2304-2015 · Apr 13, 2015 · Terminated
  ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.

…and 24 more.