SPI CONTACT INICELL 4.23.654Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640156470413), received between Oct 9, 2019 and Jan 30, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, NUMBNESS, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24219974 ↗
• InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED, RADIATION TX-HEAD / NECK AREA, XEROSTOMIA, IMMEDIATE IMPLANTATION, INFECTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23073685 ↗
• InjuryJun 28, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, UNCONTROLLED DIABETES MELLITUS, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, INFLAMMATION, MOBILITY. MM2024_1945 AND 2024_1946 ARE THE SAME PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19631005 ↗
• InjuryMar 1, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, THREAD TAP USED, IMMEDIATE IMPLANTATION, INFLAMMATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18816224 ↗
• InjuryFeb 8, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18665963 ↗
• InjuryJan 12, 2024Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, ILLNESS REQUIRING STEROIDS, XEROSTOMIA, SMOKER, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, BRUXISM, BONE RESORPTION, PAIN, MOBILITY. EXCESSIVE PRESSURE APPLIED TO IMPLANT. CROWN AND ABUTMENT REMOVED DUE TO IMPLANT FAILURE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18501655 ↗
• InjuryJan 12, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, MOBILITY. TISSUE INFILTRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18501521 ↗
• InjuryMay 23, 2023Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY((B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 16982722 ↗
• InjuryMay 8, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, XEROSTOMIA, LOCAL INFECTION SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY QUANTITY, MOBILITY

  Patient problems: Inadequate Osseointegration

  MAUDE report 16884472 ↗
• InjuryMar 29, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13938133 ↗
• InjuryDec 11, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED. SAME PATIENT AS (B)(6).

  Patient problems: No Code Available

  MAUDE report 10990255 ↗
• InjuryNov 11, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED.

  Patient problems: No Code Available

  MAUDE report 9304211 ↗
• InjuryOct 9, 2019Loss 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.

  Patient problems: No Code Available

  MAUDE report 9171638 ↗