SPI CONTACT 4.13.222Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640156471687), received between Mar 25, 2019 and Nov 10, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15770826 ↗
• InjuryJul 15, 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, BRUXISM, BONE LOSS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15025483 ↗
• 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, PERI-IMPLANTITIS, INFECTION, PAIN, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14591117 ↗
• InjuryMar 25, 2019Failure to Osseointegrate; Failure to Osseointegrate

  LOSS OF IMPLANT - DIABETES MELLITUS, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY, BONE RESORPTION, INFECTION, SWELLING, INFLAMMATION, MOBILITY (B)(6) ARE SAME PATIENT).

  Patient problems: No Code Available

  MAUDE report 8447803 ↗
• InjuryMar 25, 2019Failure to Osseointegrate; Failure to Osseointegrate

  LOSS OF IMPLANT - DIABETES MELLITUS, PERIODONTAL DISEASE, INADEQUATE BONE QUALITY/QUANTITY, BONE RESORPTION, INFECTION, SWELLING, INFLAMMATION, MOBILITY ((B)(6) ARE SAME PATIENT).

  Patient problems: No Code Available

  MAUDE report 8447801 ↗