InterActive® Gold Engaging Abutment 6534-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307109662), received between May 14, 2019 and Jun 8, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K130572); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2021Fracture; Fracture

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, IMPLANT FRACTURED AFTER DELIVERY OF PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 11956527 ↗
• InjuryApr 2, 2020Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  PER (B)(4), AFTER CLINICAL PROCEDURE, PATIENT PRESENTED WITH A FRACTURED IMPLANT CROWN. THE FRACTURE WAS AT THE BASE OF THE ABUTMENT

  Patient problems: Failure of Implant; Pain

  MAUDE report 9914825 ↗
• InjuryMay 14, 2019Fracture; Fracture

  PER COMPLAINT (B)(4), IT WAS REPORTED THAT A GOLD ENGAGING DENTAL ABUTMENT FRACTURED AT THE INTERNAL HEX AREA, WHICH REQUIRED A REMAKE OF THE ENTIRE OF THE PATIENT'S ENTIRE SCREW-RETAINED CUSTOM ABUTMENT AND CROWN. THE PATIENT LOST FUNCTION OF THEIR FIRST MOLAR AND THEIR POSTERIOR CHEWING FUNCTION WAS COMPROMISED. FOOD WOULD ALSO GET TRAPPED AS A RESULT OF THE ABUTMENT FRACTURE. INFLAMMATION WAS ALSO REPORTED. THE ABUTMENT WAS EXPLANTED FOUR YEARS AFTER INITIAL PLACEMENT.

  Patient problems: Difficulty Chewing; Inflammation

  MAUDE report 8608822 ↗
• InjuryMay 14, 2019Fracture; Fracture

  PER COMPLAINT (B)(4), IT WAS REPORTED THAT A GOLD ENGAGING DENTAL ABUTMENT FRACTURED AT THE INTERNAL HEX AREA, WHICH REQUIRED A REMAKE OF THE ENTIRE OF THE PATIENT'S ENTIRE SCREW-RETAINED CUSTOM ABUTMENT AND CROWN. THE PATIENT LOST FUNCTION OF THEIR FIRST MOLAR AND EXPERIENCED COMPROMISED CHEWING EFFICIENCY. FOOD WOULD ALSO GET TRAPPED AS A RESULT OF THE ABUTMENT FRACTURE. INFLAMMATION WAS ALSO REPORTED. THE ABUTMENT WAS EXPLANTED FIVE YEARS AFTER INITIAL PLACEMENT.

  Patient problems: Difficulty Chewing; Inflammation

  MAUDE report 8608764 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130572. One submission often covers many models, so check the product and lot details in each record.

• Z-0363-2020 · Oct 26, 2018 · Terminated
  Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
• Z-1917-2018 · Mar 14, 2018 · Terminated
  ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Produ
• Z-0539-2018 · Jan 23, 2018 · Terminated
  Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
• Z-2551-2018 · Mar 3, 2017 · Terminated
  ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermedia