SIMPLANT 37472Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532290459), received between Apr 26, 2025 and Jun 15, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Off-Label Use

  IT WAS REPORTED THAT IMPLANT PLACEMENT WAS ATTEMPTED. LAB ASSISTED SURGICAL GUIDE WAS USED AT THE TIME OF IMPLANT PLACEMENT. PUNCH, DRILL SEQUENCE, AND IMPLANT WAS PLACED. THE IMPLANT WAS TOO DEEP AND ANGLED. IMPLANT WAS TAKEN OUT AND SUTURED UP FOR AREA TO HEAL SO IT COULD BE ATTEMPTED AGAIN AT A LATER DATE.

  Patient problems: Failure of Implant

  MAUDE report 25499771 ↗
• InjuryApr 26, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ISSUE WITH SIMPLANT GUIDE FILE DS DESIGN. THE CUSTOMER CHANGED TO THE IMPLANT PLANNING TO 3.0 MM IMPLANTS ON POSITIONS # 8 AND 9 RESULTING IN OFF-LABEL USE. THE PATIENT'S IMPLANT FAILED AS A RESULT AND WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 21915437 ↗