SPI CONTACT 4.13.231Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640156471649), received between Jun 23, 2018 and Oct 17, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2022Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED - SURGICAL MISTAKE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15613561 ↗
• InjuryJul 29, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 15127671 ↗
• InjuryJul 28, 2022Failure 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.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15120032 ↗
• InjuryFeb 7, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, INFECTION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13468997 ↗
• InjuryMar 8, 2021Loss 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, SMOKER, PERIODONTAL DISEASE, BONE RESORPTION, SEVERE PERI-IMPLANTITIS, INFECTION, PAIN, SWELLING, FISTULA, ABSCESS, BLEEDING, INFLAMMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11435065 ↗
• InjuryAug 18, 2018Loss of Osseointegration; Loss of Osseointegration

  PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. BRUXISM, BONE RESORPTION, PERI-IMPLANTITIS. PATIENT IS HEAVY SMOKER AND HAS BELOW AVERAGE HOME CARE.

  Patient problems: No Code Available

  MAUDE report 7795840 ↗
• InjuryJun 23, 2018Loss of Osseointegration; Loss of Osseointegration

  PRIMARY STABILITY ACHIEVED. LOSS OF OSSEOINTEGRATION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 7632387 ↗