ALTERA 6124.0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095174564), received between Feb 8, 2022 and Nov 15, 2024 — classified as 3 malfunctions.

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

22 other recalls cover devices cleared under the same FDA submission (K140411); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE TRYING TO EXPAND AN ALTERA CAGE INSIDE A PATIENT, THE TIP OF THE DRIVER BROKE OFF INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20698600 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP OF THE INSTRUMENT BROKE OFF IN THE IMPLANT DURING EXPANSION AND WAS UNABLE TO BE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 18810689 ↗
• MalfunctionFeb 8, 2022Break

  IT WAS REPORTED THAT THE TIP OF (1) ALTERA THREADED ROD BROKE OFF INTO THE CAGE DURING IMPLANTATION. THE CAGE WITH THE BROKEN TIP WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13486148 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140411. One submission often covers many models, so check the product and lot details in each record.

• Z-2863-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15
• Z-2858-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8
• Z-2861-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
• Z-2862-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15
• Z-2859-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8
• Z-2867-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8
• Z-2864-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15
• Z-2850-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)
• Z-2868-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8
• Z-2860-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8
• Z-2851-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8
• Z-2865-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8
• Z-2856-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15
• Z-2857-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15
• Z-2852-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8

…and 7 more.