simply ReActive® Implant 753713URecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10841307108061), received between Sep 5, 2019 and Nov 8, 2022 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 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 15750959 ↗
• InjurySep 22, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Granuloma; Unspecified Infection

  MAUDE report 10565280 ↗
• InjuryApr 1, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 9909669 ↗
• InjuryMar 19, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis; Osteopenia/ Osteoporosis

  MAUDE report 9852642 ↗
• InjuryMar 4, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis; Inflammation

  MAUDE report 9784371 ↗
• InjuryFeb 18, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 9718963 ↗
• InjuryFeb 14, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Fibrosis

  MAUDE report 9710683 ↗
• InjuryFeb 14, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

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

  MAUDE report 9710638 ↗
• InjuryFeb 11, 2020Osseointegration Problem; Osseointegration Problem

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

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

  MAUDE report 9691443 ↗
• InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; No Information

  MAUDE report 9050830 ↗
• InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE DUE TO INFECTION.

  Patient problems: Failure of Implant; Inflammation; Unspecified Infection

  MAUDE report 9022359 ↗
• InjurySep 9, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLIANT (B)(4), IMPLANT FAILED TO INTEGRATE. PATIENT EXPERIENCED INFLAMMATION AND FIBROUS TISSUE AROUND THE IMPLANT.

  Patient problems: Failure of Implant; Fibrosis; Inflammation

  MAUDE report 8975660 ↗
• InjurySep 5, 2019Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, IT WAS REPORTED THAT PATIENT HAD EXPERIENCED TORQUED IMPLANT AND IT WAS NOT INTEGRATED. ADDITIONALLY, THE PATIENT REPORTED PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8963712 ↗