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Excella II® E2002Recalls & reported problems

INNO Holdings, Inc. · Ti 6Al 4V (ELI) · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M711E20020), received between Dec 7, 2022 and Dec 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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

  • Improper or Incorrect Procedure or Method1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 7, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    EVENT OCCURRED IN (B)(4), PERU WHEREIN A PATIENT HAD A SPINAL DEFORMITY CONSTRUCT OF MULTIPLE PEDICLE SCREWS IMPLANTED WITH RODS AND LOCKING CAPS. AT A TWO-WEEK POST-OPERATIVE FOLLOW-UP, THE PATIENT HAD NOTICEABLE DEFORMITY, PAIN AND FUNCTIONAL LIMITATION. IMAGING SHOWED MULTIPLE LOCKING CAPS CAME LOOSE, RELEASING THE RODS FROM THE CONSTRUCT IN THE LUMBOSACRAL AREA. REVISION SURGERY WAS PERFORMED TO REPLACE 8 OF THE ORIGINAL 18 SCREWS AND LOCKING CAPS, WHILE THE REMAINING SCREWS, LOCKING CAPS AND RODS REMAINED.

    Patient problems: Pain

    MAUDE report 15933630 ↗

Other Appliance, Fixation, Spinal Intervertebral Body devices

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