SPI ELEMENT INICELL 4.23.554Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07640156470017), received between Feb 25, 2019 and May 28, 2026 — classified as 12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, THREAD TAP USED, DISEASED MUCOUS MEMBRANE, PAIN, SWELLING, ABSCESS, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25315373 ↗
• InjuryMar 21, 2025Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21662070 ↗
• 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, IMMEDIATE IMPLANTATION, INADEQUATE BONE QUALITY/QUANTITY, PAIN, INFLAMMATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19630988 ↗
• InjuryFeb 8, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, NO THREAD TAP USED, SMOKER, DISEASED MUCOUS MEMBRANE, IMMEDIATE IMPLANTATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18665940 ↗
• InjuryNov 22, 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, MOBILITY. EVEN WITH THE EXCELLENT INITIAL STABILITY, ONE OF TWO IMPLANTS FAILED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15845826 ↗
• InjuryOct 14, 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, XEROSTOMIA, HEAVY SMOKER, PERIODONTAL DISEASE, IMMEDIATE IMPLANTATION, INFECTION. SECOND TIME #27 FAILED, WHICH IS WHY RESTORATION DATE PRECEDES ABUTMENT DATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15602934 ↗
• InjuryJun 3, 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, PSYCHOLOGICAL DISORDER, BRUXISM, PAIN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14588065 ↗
• InjuryOct 31, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED - IMPLANT WAS PLACED RIGHT AFTER EXPLANTATION OF AN OLDER IMPLANT - IMPLANT DIAMETER WAS TOO BIG.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12725534 ↗
• InjuryJun 22, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12038684 ↗
• InjuryFeb 5, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 11285738 ↗
• InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED. 6.0 IMPLANT PLACED AND WAS TOO WIDE, CHANGED TO 5.0 BUT WAS GOING TO BE TOO LONG AND PLACED 5.0X9.5L. SAME PATIENT AS (B)(6).

  Patient problems: No Code Available

  MAUDE report 10383685 ↗
• InjuryFeb 25, 2019Failure to Osseointegrate; Failure to Osseointegrate

  NO OSSEOINTEGRATION, THREAD TAP USED, IMPLANT WAS COMPLETELY COVERED BY BONE, IMMEDIATE IMPLANTATION, INFECTION, MOBILITY CHECK-UP AND LASER DONE THE SAME DAY.

  Patient problems: No Code Available

  MAUDE report 8365913 ↗