SPI CONTACT 4.13.244Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640156471564), received between Jan 2, 2020 and Apr 25, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, SWELLING, MOBILITY (B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 16807458 ↗
• InjuryApr 25, 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, LOCAL INFECTION / SUBACUTE CHRONIC OSTEITIS, INFECTION, SWELLING, MOBILITY (B)(6) ARE SAME PATIENT).

  Patient problems: Inadequate Osseointegration

  MAUDE report 16807440 ↗
• InjuryJan 2, 2020Failure to Osseointegrate; Failure to Osseointegrate

  IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, MOBILITY.

  Patient problems: No Code Available

  MAUDE report 9537312 ↗