SPI ELEMENT 4.13.908Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640156470819), received between May 11, 2018 and Sep 28, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Loss of Osseointegration

  Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, thread tap used, smoker, peri-implantitis, swelling.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50911085 ↗
• InjuryJul 6, 2026Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, INFECTION, INCREASED SENSITIVITY, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25715039 ↗
• InjuryJan 9, 2025Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21109684 ↗
• InjuryJun 14, 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, SINUS PERFORATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19535837 ↗
• InjuryApr 25, 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, COMPLICATION IN SITE PREPARATION, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, INFECTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16806071 ↗
• InjuryJul 29, 2022Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, MOBILITY

  Patient problems: Inadequate Osseointegration

  MAUDE report 15127672 ↗
• InjuryJun 15, 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, BONE RESORPTION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 10152050 ↗
• InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: No Code Available

  MAUDE report 8978541 ↗
• InjuryNov 24, 2018Loss of Osseointegration; Loss of Osseointegration

  PRIMARY STABILITY ACHIEVED, NO OSSEOINTEGRATION. PATIENT HAS BLOOD COAGULATION DISORDER AND DIABETES MELLITUS. AT TIME OF SURGERY PERIODONTAL DISEASE AND LOCAL INFECTION/SUBACUTE CHRONIC OSTEITIS. MOBILITY.

  Patient problems: No Code Available

  MAUDE report 8100153 ↗
• InjuryMay 11, 2018Loss of Osseointegration; Loss of Osseointegration

  SINUS INFECTION, INCREASED SENSITIVITY, MOBILITY, LOSS OF IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7506572 ↗