SIMPLY ICONIC™ Implant 674713RPRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10841307125204), received between Sep 8, 2023 and Jun 23, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25601280 ↗
• InjuryJun 18, 2026Osseointegration Problem

  LACK OF PRIMARY STABILITY.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550030 ↗
• InjuryApr 16, 2026Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  TRAUMA / CLINICAL COMPLICATION ONLY.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905389 ↗
• InjuryApr 11, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848140 ↗
• InjuryMar 31, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747189 ↗
• InjuryMar 13, 2026Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595311 ↗
• InjuryJan 2, 2026Malposition of Device

  LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951008 ↗
• InjuryNov 5, 2025Positioning Failure; Osseointegration Problem; Positioning Failure; Osseointegration Problem

  LACK OF PRIMARY STABILITY.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475056 ↗
• InjuryNov 5, 2025Malposition of Device; Malposition of Device

  LACK OF PRIMARY STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23474200 ↗
• InjuryMar 27, 2025Premature Separation; Premature Separation

  PART NOT RETAINED ON MATING PART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714033 ↗
• InjuryMar 27, 2025Malposition of Device; Malposition of Device

  LACK OF PRIMARY STABILITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714032 ↗
• InjuryMar 26, 2025Labelling, Instructions for Use or Training Problem; Inadequacy of Device Shape and/or Size; Labelling, Instructions for Use or Training Problem; Inadequacy of Device Shape and/or Size

  USABILITY - WRONG PART USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702583 ↗
• MalfunctionFeb 24, 2025Degraded; Degraded

  PART NOT RETAINED ON MATING PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453592 ↗
• InjuryMay 18, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 19348246 ↗
• InjuryApr 29, 2024Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 19206562 ↗
• InjuryDec 16, 2023Positioning Failure; Positioning Failure

  LACK OF PRIMARY STABILITY.

  Patient problems: Abscess; Failure of Implant

  MAUDE report 18341648 ↗
• InjurySep 8, 2023Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 17710858 ↗
• InjurySep 8, 2023Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4) AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 17710827 ↗