simply ReActive® Implant 754710URecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10841307108146), received between Aug 28, 2019 and Sep 15, 2023 — classified as 18 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (9 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.

• InjurySep 15, 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; Granuloma; Osteopenia/ Osteoporosis

  MAUDE report 17758012 ↗
• InjuryApr 20, 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; Granuloma; Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection

  MAUDE report 16775682 ↗
• InjuryJan 24, 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; Osteopenia/ Osteoporosis

  MAUDE report 16231156 ↗
• InjuryJul 8, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 14955776 ↗
• InjuryJul 4, 2022Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 14906460 ↗
• InjuryJul 4, 2022Positioning Failure; Positioning Failure

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

  Patient problems: Failure of Implant; Sinus Perforation

  MAUDE report 14906457 ↗
• InjuryJun 17, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 14733450 ↗
• InjurySep 23, 2021Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Fibrosis; Granuloma; Unspecified Infection; Wound Dehiscence

  MAUDE report 12518910 ↗
• InjurySep 23, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Granuloma; Unspecified Infection

  MAUDE report 12518904 ↗
• InjuryJul 16, 2021Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Granuloma

  MAUDE report 12179755 ↗
• InjuryMar 23, 2021Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 11552297 ↗
• InjuryMar 5, 2021Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 11419799 ↗
• InjuryOct 12, 2020Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 10662708 ↗
• InjuryApr 2, 2020Positioning Problem; Positioning Problem

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

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

  MAUDE report 9914841 ↗
• InjuryDec 27, 2019Positioning Problem; Positioning Problem

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

  Patient problems: Failure of Implant; Organ Dehiscence

  MAUDE report 9522921 ↗
• InjuryNov 28, 2019Positioning Problem; Positioning Problem

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

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

  MAUDE report 9388184 ↗
• InjurySep 10, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT: (B)(4), DURING THE TIME OF EXTRACTION, PATIENT EXPERIENCED FAILURE OR LOSS OF IMPLANT TO INTEGRATE WITH BONE LOSS AROUND THE IMPLANT.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 8979650 ↗
• InjuryAug 28, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING UNCOVERING OF IMPLANT, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE. TISSUE INVAGINATION WAS NOTED, IMPLANT WAS REMOVED AND BONE GRAFT WAS PLACED.

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

  MAUDE report 8938500 ↗