SPI CONTACT INICELL 4.23.646Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640156470451), received between Oct 28, 2018 and Apr 7, 2026 — classified as 9 injuries.

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

• InjuryApr 7, 2026Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION (B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 24801066 ↗
• InjuryOct 1, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION ((B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 20341552 ↗
• InjuryOct 1, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION ((B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 20341550 ↗
• InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, BONE RESORPTION, INFECTION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20332298 ↗
• InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SMOKER, INFECTION, PAIN, BLEEDING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20332094 ↗
• InjurySep 6, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12427931 ↗
• InjurySep 21, 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, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 10559294 ↗
• InjuryJun 7, 2019Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED BY BONE, PAIN. IMPLANT BECAME LOOSE CAUSING IRRITATION.

  Patient problems: No Code Available

  MAUDE report 8677718 ↗
• InjuryOct 28, 2018Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT FAILURE. PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. AT THE TIME OF SURGERY LOCAL INFECTION/SUBACUTE CHRONIC OSTEITIS. INFECTION, PAIN, SWELLING, MOBILITY. IMPLANT BECAME INFECTED DUE TO POOR HYGIENE AROUND THE IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8012275 ↗