SPI ELEMENT INICELL 4.23.712Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640156470338), received between Apr 9, 2019 and Apr 8, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24813392 ↗
• InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, INFECTION, PAIN ((B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 22736521 ↗
• InjuryJun 9, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, SMOKER, INADEQUATE BONE QUALITY/QUANTITY, BONE RESORPTION, INCREASED SENSITIVITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19495124 ↗
• InjuryJun 6, 2024Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED, MOBILITY. WHEN LOOSENING THE GINGIVA FORMER, THE IMPLANT LOOSENED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19474407 ↗
• InjuryMay 18, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19348004 ↗
• InjuryMay 25, 2023Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, DISEASED MUCOUS MEMBRANE, COMPLICATION IN SITE PREPARATION, PERI-IMPLANTITIS, PAIN, SWELLING, FISTULA, INFLAMMATION

  Patient problems: Inadequate Osseointegration

  MAUDE report 17002693 ↗
• InjuryNov 1, 2022Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, DIABETES MELLITUS, PERI-IMPLANTITIS, MOBILITY(B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 15705723 ↗
• InjurySep 6, 2021Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, INFLAMMATION ((B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 12427961 ↗
• InjuryApr 9, 2019Failure to Osseointegrate; Failure to Osseointegrate

  COMPLICATION IN SITE PREPARATION (STRESS), NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, PERI-IMPLANTITIS, MOBILITY (B)(6) ARE SAME PATIENT).

  Patient problems: No Code Available

  MAUDE report 8494868 ↗