Nex-D2 CBZB005-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840314121103), received between Aug 9, 2025 and Jan 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Break

  DURING LUMBAR SPINE SURGERY, A BONE TAP MIS 4.5 MM FRACTURED DURING NORMAL USE. THE DISTAL TIP OF THE BONE TAP REMAINED RETAINED WITHIN THE PATIENT'S BONE AND COULD NOT BE RETRIEVED INTRAOPERATIVELY. NO PATIENT INJURY, ADVERSE CLINICAL OUTCOME, OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION RELATED TO HARM WAS REPORTED. THE DEVICE DID NOT PERFORM AS INTENDED. THE EVENT IS CONSIDERED A DEVICE MALFUNCTION WITH POTENTIAL FOR SERIOUS INJURY IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222175 ↗
• MalfunctionSep 8, 2025Material Fragmentation; Device Damaged by Another Device; Material Fragmentation; Device Damaged by Another Device

  DURING FIXATION OF L4 AND L5 VERTABREA THE TIP OF THE BONE TAP 4.5MM PN CBZB005-45 LN 0001217C1 BROKE WHILE TAPPING L5. A SNAPPING SOUND WAS HEARD AND FRAGMENTS OF THE TIP OF THE BONE TAP BECAME LODGED INSIDE THE BONE AND COULD NOT BE REMOVED. L5 WAS SKIPPED AND INSTEAD S1 WAS USED IN ITS PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22997742 ↗
• MalfunctionAug 9, 2025Material Fragmentation; Device Damaged by Another Device; Material Fragmentation; Device Damaged by Another Device

  ON (B)(6) 2025, DURING A SURGICAL OPERATION PROCEDURE INVOLVING SPINAL FIXATION OF THE VERTEBRA T8 AND T9, COMPLICATIONS AROSE WITH THE INSTRUMENTATION. WHILE TAPPING THE VERTEBRAE, THE TIP OF THE INITIAL 4.5MM BONE TAP FRACTURED AND BECAME LODGED WITHIN THE T8 VERTEBRAL BODY. SUBSEQUENTLY, A SECOND 4.5MM BONE TAP WAS USED FOR T9, THE TIP OF THIS BONE TAP ALSO BECAME LODGED. RESULTING IN TWO SPERATE BONE TAP FRAGMENTS RETAINED WITHIN THE RESPECTIVE VERTEBRAE (T8 AND T9).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22766514 ↗