SPI ELEMENT INICELL 4.23.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07640156478556), received between Jul 1, 2019 and Jul 10, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, INFECTION, SWELLING

  Patient problems: Inadequate Osseointegration

  MAUDE report 25775624 ↗
• InjuryJan 13, 2026Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, SMOKER, BONE RESORPTION, PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, ABSCESS, BLEEDING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24050930 ↗
• InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, SMOKER, INFECTION, PAIN, INCREASED SENSITIVITY, BLEEDING, INFLAMMATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23631064 ↗
• InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22881897 ↗
• InjuryMar 28, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, PERI-IMPLANTITIS, PAIN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21719698 ↗
• InjuryMar 6, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION

  Patient problems: Inadequate Osseointegration

  MAUDE report 21533566 ↗
• InjuryJun 18, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, SMOKER, PERIODONTAL DISEASE, BRUXISM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19556580 ↗
• InjuryFeb 17, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, ABSCESS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18728194 ↗
• InjuryFeb 8, 2024Loss 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, XEROSTOMIA, PERIODONTAL DISEASE, BRUXISM, PERI-IMPLANTITIS, INFECTION, INFLAMMATION, MOBILITY. IMPLANT 11 WAS PLACED INTO A HIGHLY COMPRIMIZED SITE. LIMITED FACIAL CORTICAL PLACE / THIN COVERING IMPLANT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18665968 ↗
• InjuryJan 11, 2022Loss 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, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13222401 ↗
• InjuryAug 24, 2021Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12358895 ↗
• InjuryDec 9, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED.

  Patient problems: No Code Available

  MAUDE report 10973889 ↗
• InjuryJul 27, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, COMPLICATION IN SITE PREPARATION.

  Patient problems: No Code Available

  MAUDE report 10324913 ↗
• InjuryFeb 28, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERHAPS BIOMECHANICAL OVERLOAD, PAIN, MOBILITY, IMMEDIATE LOAD.

  Patient problems: No Code Available

  MAUDE report 9768179 ↗
• InjuryJan 2, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, INFECTION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 9537309 ↗
• InjuryJul 12, 2019Failure to Osseointegrate; Failure to Osseointegrate

  NO OSSEOINTEGRATION, THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED BY BONE, MOBILITY. DISCOMFORT, NOT PAIN. POSSIBLY TOO HIGH OF TORQUE ACHIEVED AT IMPLANT PLACEMENT. WHEN TRYING TO UNSCREW THE HEALING CAP, THE ENTIRE IMPLANT CAME OUT WITH NO FORCE EXERTED ON THE IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8784270 ↗
• InjuryJul 1, 2019Failure to Osseointegrate; Failure to Osseointegrate

  NO THREAD TAP USED, IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, IMPLANT WASN'T COMPLETELY COVERED BY BONE, INADEQUATE BONE QUALITY/QUANTITY.

  Patient problems: No Code Available

  MAUDE report 8747280 ↗