Skip to content

Millennium Z16113001Recalls & reported problems

Avalign Technologies, Inc. · K-Wire, Ø1.4mm, threaded, pointed tip, thread length 25mm, overall length 457mm, single use · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190776135072), received between Jan 24, 2020 and Jan 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Detachment of Device or Device Component2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 24, 2020Break; Detachment of Device or Device Component

    K-WIRE WAS INSERTED INTO VERTEBRAL BONE. SCREW WAS PLACED OVERK-WIRE, K-WIRE WAS SCREWED INTO THE SPACE AND THE TIP OF THE K-WIRE BROKE OFF. K-WIRE BROKE OFF IN THE SPINAL CORD AREA. DR. RETRIEVED. THIS K-WIRE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9630177 ↗
  • MalfunctionJan 24, 2020Break; Detachment of Device or Device Component

    K-WIRE WAS INSERTED INTO VERTEBRAL BONE. SCREW WAS PLACED OVERK-WIRE, K-WIRE WAS SCREWED INTO THE SPACE AND THE TIP OF THE K-WIRE BROKE OFF.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9630175 ↗

Other Pin, Fixation, Threaded devices

All Pin, Fixation, Threaded devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.