SPI CONTACT 4.13.230Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640156471656), received between Sep 10, 2019 and Jan 31, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, THREAD TAP USED ((B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 18612284 ↗
• InjuryAug 16, 2023Break; Break

  IMPLANT FRACTURE, LOSS OF OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, PAIN, INCREASED SENSITIVITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17556095 ↗
• InjuryJun 22, 2023Loss 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, IMMEDIATE IMPLANTATION, INCREASED SENSITIVITY, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17180643 ↗
• InjuryOct 20, 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, INFECTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15637246 ↗
• InjuryOct 20, 2022Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PERI-IMPLANTITIS, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15637229 ↗
• InjuryFeb 7, 2022Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, BISPHOSPHONATE TREATMENT, SMOKER, PERIODONTAL DISEASE, COMPLICATION IN SITE PREPARATION, INADEQUATE BONE QUALITY/QUANTITY, PERI-IMPLANTITIS, INFECTION, INFLAMMATION, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13468579 ↗
• InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, IMMEDIATE IMPLANTATION, INFECTION, PAIN.

  Patient problems: No Code Available

  MAUDE report 8978629 ↗