ScrewPlant® Implant 103716Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307104940), received between Nov 27, 2019 and Oct 13, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K061319); 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.

• InjuryOct 13, 2022Fracture; Fracture

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

  Patient problems: Failure of Implant; Granuloma; Osteopenia/ Osteoporosis; Wound Dehiscence

  MAUDE report 15594512 ↗
• InjuryMay 19, 2021Positioning Problem; Positioning Problem

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

  Patient problems: Failure of Implant

  MAUDE report 11848484 ↗
• InjuryJan 22, 2021Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 11214686 ↗
• InjuryNov 27, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Inflammation; Unspecified Infection

  MAUDE report 9380890 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061319. One submission often covers many models, so check the product and lot details in each record.

• Z-0010-2020 · Aug 7, 2018 · Terminated
  ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousa
• Z-2376-2018 · May 18, 2018 · Terminated
  REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
• Z-2125-2017 · May 2, 2017 · Terminated
  Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
• Z-2320-2016 · Jul 5, 2016 · Terminated
  RePlant Angled Abutment Part Number 6050-52-60