RePlus® Implant 704710Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841307104292), received between Jul 30, 2018 and Jun 21, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2023Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 17168408 ↗
• InjuryJul 13, 2021Loss of Osseointegration; Loss of Osseointegration

  PER (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 12158755 ↗
• InjuryJun 3, 2021Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11927431 ↗
• InjuryJan 24, 2020Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 9626594 ↗
• InjuryNov 27, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 9387991 ↗
• InjuryOct 18, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 9207960 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 9097619 ↗
• InjurySep 9, 2019Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 8976570 ↗
• InjuryJul 30, 2018Failure to Osseointegrate; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Failure to Osseointegrate; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  THIS REPORT SUMMARIZES 2403 INJURY COMPLAINTS ASSOCIATED WITH CLASS II, ENDOSSEOUS DENTAL IMPLANTS (DZE) FOR REPORTING QUARTER 2; APRIL 1, 2018 THROUGH JUNE 30, 2018. IT CONTAINS INFORMATION ON EARLY IMPLANT FAILURES AND LATE OR LONG-TERM IMPLANT FAILURES. EARLY FAILURES INCLUDE CASES OF FAILURE TO OSSEOINTEGRATE OR POSITIONING PROBLEMS, I.E. LACK OF PRIMARY STABILITY. OSSEOINTEGRATION OCCURS WHEN BONE CELLS ATTACH THEMSELVES DIRECTLY TO THE TITANIUM SURFACE, ESSENTIALLY LOCKING THE IMPLANT INTO THE BONE. IN CASES OF LACK OF OSSEOINTEGRATION, THIS HAS NOT BEEN ACHIEVED. POSITIONING IS CONSIDERED THE KEY FACTOR IN CLINICAL SUCCESS OF AN IMPLANT IN THE SHORT TERM. WITH POSITIONING FAILURE, PRIMARY MECHANICAL STABILITY CANNOT BE ACHIEVED. LATE OR LONG-TERM FAILURE INCLUDE CASES OF LOSS OF INTEGRATION. IN LOSS OF INTEGRATION, AN IMPLANT HAS INITIALLY OSSEOINTEGRATED INTO THE BONE, HOWEVER, OVER TIME BONE LOSS MAY HAVE OCCURRED AROUND THE IMPLANT SITE, REQUIRING THE REMOVAL OF THE IMPLANT. THIS ASR REPORT WILL PROVIDE A SUMMARY OF COMPLAINTS DEEMED AS SERIOUS INJURIES DUE TO NECESSITATING MEDICAL OR SURGICAL INTERVENTION. DEVICE PROBLEM CODES REPORTED: FAILURE TO OSSEOINTEGRATE, POSITIO

  Patient problems: Abscess; Anxiety; Asthma; Autoimmune Disorder; Cancer; Discharge; Discomfort; Edema; Failure of Implant; Fistula; Granuloma; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Hyperplasia; Impaired Healing; Infiltration into Tissue; Inflammation; Nerve Damage; No Code Available; No Consequences Or Impact To Patient; No Information; Osteolysis; Osteopenia/ Osteoporosis; Pain; Swelling; Thyroid Problems; Unspecified Infection; Wound Dehiscence

  MAUDE report 7732860 ↗