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Amendia 10-07Recalls & reported problems

Spinal Elements · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840916101367), received between Nov 29, 2021 and Nov 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Mechanical Problem1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • MalfunctionNov 29, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    REPORTEDLY PATIENT RECEIVED SPINAL FUSION POSTERIOR FIXATION FROM L3-L5. NO INDEX SURGERY DETAILS WERE PROVIDED. REVISION WAS PLANNED TO TIGHTEN THREE LOOSE LOCKING SCREWS AND EXTEND CONSTRUCT TO S1. REVISION WAS POSTPONED AND NO FURTHER SURGICAL INFORMATION OR DEVICE DETAILS WERE PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 12888724 ↗

Other Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices

All Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease devices →

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