SPI ELEMENT 4.13.922Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640156471434), received between Jul 20, 2020 and Mar 6, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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. 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.

• InjuryMar 6, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, ABSCESS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24528740 ↗
• InjuryMar 9, 2023Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INFECTION, INFLAMMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16511868 ↗
• InjuryJul 20, 2020Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERI-IMPLANTITIS, INFECTION, SWELLING, FISTULA, ABSCESS, INFLAMMATION.

  Patient problems: No Code Available

  MAUDE report 10294283 ↗