SPI CONTACT 4.13.221Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07640156471694), received between Jan 25, 2019 and May 9, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, PERI-IMPLANTITIS, MOBILITY ((B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 21992009 ↗
• InjuryJul 16, 2024Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 19747973 ↗
• InjuryApr 28, 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, PAIN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16829135 ↗
• InjuryOct 17, 2022Failure to Osseointegrate; Failure to Osseointegrate

  PRIMARY STABILITY NOT ACHIEVED - WRONG IMPLANT SIZE WAS CHOSEN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15615547 ↗
• InjurySep 29, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15508278 ↗
• InjuryMar 8, 2022Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, SMOKER, MOBILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13691803 ↗
• 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, COMPLICATION IN SITE PREPARATION, BONE RESORPTION, INFLAMMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13469053 ↗
• InjuryFeb 6, 2022Failure to Osseointegrate; Failure to Osseointegrate

  LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, MOBILITY (2022_0206 AND 2022_0207 ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 13467155 ↗
• InjuryFeb 15, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 11326925 ↗
• InjuryNov 30, 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, SMOKER.

  Patient problems: No Code Available

  MAUDE report 10917072 ↗
• InjuryNov 30, 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, IMMEDIATE IMPLANTATION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 10917054 ↗
• InjuryNov 27, 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, PAIN, SWELLING, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 10913166 ↗
• InjuryOct 23, 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, INFECTION, NUMBNESS, MOBILITY. A TEMPORARY CROWN WAS PLACED, THE DAY AFTER SURGERY. THE TEMPORARY CROWN BEGAN TO MOVE UNTIL IT HAD TO BE REMOVED.

  Patient problems: No Code Available

  MAUDE report 10724398 ↗
• InjuryMar 18, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SWELLING, BLEEDING, MOBILITY ((B)(6) ARE SAME PATIENT).

  Patient problems: No Code Available

  MAUDE report 9847266 ↗
• InjuryMar 18, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, SWELLING, BLEEDING, MOBILITY ((B)(4) ARE SAME PATIENT).

  Patient problems: No Code Available

  MAUDE report 9847262 ↗
• InjuryFeb 17, 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. ONE WEEK AFTER REOPENING, THE IMPLANT WAS VERY MOBILE. INSERTION TORQUE 30 NCM.

  Patient problems: No Code Available

  MAUDE report 9716302 ↗
• InjuryFeb 5, 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, BONE RESORPTION, MOBILITY, 1 OF 4 IMPLANTS DIDN'T OSSEOINTEGRATE.

  Patient problems: No Code Available

  MAUDE report 9669567 ↗
• InjuryOct 29, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PERIODONTAL DISEASE, PAIN, INCREASED SENSITIVITY, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 9249334 ↗
• InjurySep 16, 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, PERIODONTAL DISEASE, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INADEQUATE BONE QUALITY/QUANTITY, PRECEDING/SIMULTANEOUS BONE AUGMENTATION, INFECTION, PAIN, SWELLING, INFLAMMATION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 9068998 ↗
• InjurySep 2, 2019Loss of Osseointegration; Loss of Osseointegration

  LOSS OF OSSEOINTEGRATION, NO THREAD TAP USED, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED BY BONE, PAIN, SWELLING.

  Patient problems: No Code Available

  MAUDE report 8953370 ↗
• InjuryMay 20, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 8622934 ↗
• InjuryJan 25, 2019Failure to Osseointegrate; Failure to Osseointegrate

  NO OSSEOINTEGRATION, PATIENT SMOKER. (B)(6) AND (B)(6) ARE SAME PATIENT.

  Patient problems: No Code Available

  MAUDE report 8277504 ↗