SPI ELEMENT 4.13.944Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640156471359), received between Jan 28, 2019 and Jun 11, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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.

• InjuryJun 11, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 22183397 ↗
• InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19918057 ↗
• InjuryMay 10, 2024Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED. ANOTHER IMPLANT HAS BEEN PLACED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19283592 ↗
• InjuryOct 24, 2023Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, DIABETES MELLITUS, SMOKER, PAIN, INFLAMMATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17993789 ↗
• InjuryJul 12, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, NUMBNESS, BLEEDING, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17303820 ↗
• InjuryJun 22, 2023Failure 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. UNNOTICEABLE WOUND HEALING WITHOUT MARGINAL INFLAMMATION. LACK OF OSSEOINTEGRATION OF THE IMPLANT DETECTED DURING IMPRESSION TAKING (PRESSURE PAIN).

  Patient problems: Inadequate Osseointegration

  MAUDE report 17180675 ↗
• InjuryFeb 3, 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, SMOKER, BIOMECHANICAL OVERLOAD, BRUXISM, PRECEDING/SIMULTANEOUS BONE AUGMENTATION. THE LOOSENING PROBABLY OCCURRED DURING THE INSERTION OF THE NOVALOC ABUTMENT OR DUE TO OVERLOADING. THE 2ND IDENTICAL IMPLANT #16 IS IN FUNCTION.

  Patient problems: No Code Available

  MAUDE report 9658500 ↗
• InjuryDec 17, 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, ILLNESS REQUIRING STEROIDS, SMOKER, BIOMECHANICAL OVERLOAD, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, INFECTION, FISTULA, BLEEDING, INFLAMMATION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 9479194 ↗
• InjuryJan 28, 2019Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION - PRIMARY STABILITY WAS ACHIEVED, IMPLANT ACHIEVED OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE. PROGRESSIVE BONE LOSS.

  Patient problems: No Code Available

  MAUDE report 8281181 ↗