ALTERA 6124.0002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889095174557), received between Jul 7, 2021 and Sep 9, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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.

• MalfunctionSep 9, 2022Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO INSERT AN ALTERA CAGE MET RESISTANCE AND THEN A DURAL TEAR WAS OBSERVED AND FIXED INTRAOPERATIVELY. THERE ARE NO KNOWN SIDE EFFECTS AFTER SURGERY.

  Patient problems: Laceration(s)

  MAUDE report 15392015 ↗
• InjuryMay 25, 2022Use of Device Problem

  IT WAS REPORTED THAT DURING SURGERY A VEIN WAS PUNCTURED CAUSING THE PATIENT SIGNIFICANT BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 14498442 ↗
• InjuryJul 7, 2021Device Slipped

  IT WAS REPORTED BY A REPRESENTATIVE FROM THE (B)(6) THAT WHILE IMPACTING A LOADED ALTERA INSERTER WITH A MALLET, THE IMPLANT SLIPPED, PUSHING THE TIP OF THE INSERTER FORK OFF THE CAGE AND PUNCTURED THE RIGHT SIDE OF THE PATIENT'S DURA, CAUSING A DURAL LEAK.

  Patient problems: Cerebrospinal Fluid Leakage; Perforation

  MAUDE report 12131694 ↗

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-2862-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15
• Z-2871-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15
• Z-2861-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8
• Z-2868-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8
• Z-2866-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8
• Z-2869-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15
• Z-2854-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8
• Z-2860-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8
• Z-2867-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8
• Z-2857-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15
• Z-2851-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8
• Z-2855-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15
• Z-2853-2020 · Jul 22, 2020 · Terminated
  ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 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

…and 7 more.