NA EMAX2-HCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384002031), received between Dec 8, 2017 and Dec 4, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

70 other recalls cover devices cleared under the same FDA submission (K011444); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 4 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL DISCECTOMY SURGICAL PROCEDURE (UNDER MICROSCOPE), IT WAS OBSERVED THAT THE MOTOR DEVICE, WHILE BEING USED WITH A HANDSET DEVICE, BURR DEVICE AND AN ATTACHMENT DEVICE, WAS CONTINUALLY OVERHEATING. IT WAS REPORTED THAT DUE TO LIMITED DRILL AVAILABILITY AT THE TIME, THE USER PERSEVERED REDUCING THE LENGTH OF THE DUTY CYCLE (TIME OF CONTINUED USE) TO ALLOW THE DRILL TO COOL IN BETWEEN USES. IT WAS FURTHER REPORTED THAT DURING BONE SMOOTHING AT THE POSTERIOR AND CERVICAL END PLATE AND NEAR THE SPINAL CORD, THE USER OBSERVED A COMBINATION OF DARK FLUID AND WHAT APPEARED TO BE DARKER METAL FILINGS WHICH SPRAYED INTO THE DISC SPACE. IT WAS AT THIS POINT THAT THE USER STOPPED DRILLING AND PROCEEDED TO LIBERALLY IRRIGATE THE AREA IN ORDER TO COOL THE LIQUID THAT MAY HAVE BEEN HOT IN ORDER TO PREVENT DAMAGE TO THE CORD. IT WAS REPORTED THAT AFTER SEVERAL MINUTES THE USER AND ASSISTANT WERE ABLE TO SUCK UP THE FLUID ALONG WITH ANY FOREIGN DEBRIS. AFTER CAREFUL INSPECTION OF THE SURGICAL SITE, THE SURGEON CONTINUED THE DISCECTOMY AND FUSION WITHOUT THE USE OF THE DRILL. IT WAS REPORTED THAT THERE WAS A 15

  Patient problems: Foreign Body In Patient

  MAUDE report 9412143 ↗
• MalfunctionDec 8, 2017Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED CERVICAL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR DEVICE COULD NOT SECURE ATTACHMENT DEVICES. IT WAS FURTHER REPORTED THAT THE HAND CONTROL DEVICE WOULD NOT GO INTO THE LOCK POSITION WHILE IN USE WITH THE MOTOR DEVICE. AS A RESULT, THERE WAS A TWENTY-NINE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE, AND THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011444. One submission often covers many models, so check the product and lot details in each record.

• Z-0923-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
• Z-0924-2023 · Dec 7, 2022 · Open, Classified
  Pediatric Craniotome Ref:CRANI-P-G1
• Z-0920-2023 · Dec 7, 2022 · Open, Classified
  7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
• Z-0916-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
• Z-0922-2023 · Dec 7, 2022 · Open, Classified
  7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
• Z-0921-2023 · Dec 7, 2022 · Open, Classified
  Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
• Z-0918-2023 · Dec 7, 2022 · Open, Classified
  Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
• Z-0917-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and crani
• Z-0919-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
• Z-1999-2017 · Oct 6, 2016 · Terminated
  11.0cm Long Attachment Product Usage: Pneumatic system
• Z-1954-2017 · Oct 6, 2016 · Terminated
  Foot Control without Switches, SC2100 Product Usage: Electric system
• Z-1988-2017 · Oct 6, 2016 · Terminated
  Rotating Adult Craniotome Product Usage: Pneumatic system
• Z-1932-2017 · Oct 6, 2016 · Terminated
  AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
• Z-1985-2017 · Oct 6, 2016 · Terminated
  6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
• Z-2000-2017 · Oct 6, 2016 · Terminated
  10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system

…and 55 more.