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NobelReplace® 37292 (UDI 07332747160727)Recalls & reported problems

Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 4.3x11.5mm · Class 2 · Implant

Quick summary

This NobelReplace Conical Connection implant is a root-form device placed in bone. Its 2,909 adverse event reports mostly describe implants that fail to fuse with the bone or later lose that bond, and some mention fractures, infection, pain and numbness. The reports include no deaths and 2,868 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
2,944
Deaths reported
0
Injuries reported
2,903
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2,944 adverse event reports that list this exact device (DI 07332747160727), received between Oct 29, 2021 and Sep 30, 2026 — classified as 2,903 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2,326 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 50 reportsDec 2023: 41 reportsJan 2024: 53 reportsFeb 2024: 35 reportsMar 2024: 47 reportsApr 2024: 54 reportsMay 2024: 26 reportsJun 2024: 36 reportsJul 2024: 40 reportsAug 2024: 41 reportsSep 2024: 35 reportsOct 2024: 50 reportsNov 2024: 87 reportsDec 2024: 66 reportsJan 2025: 82 reportsFeb 2025: 40 reportsMar 2025: 112 reportsApr 2025: 22 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 284 reportsAug 2025: 80 reportsSep 2025: 39 reportsOct 2025: 38 reportsNov 2025: 78 reportsDec 2025: 94 reportsJan 2026: 62 reportsFeb 2026: 54 reportsMar 2026: 54 reportsApr 2026: 84 reportsMay 2026: 59 reportsJun 2026: 67 reportsJul 2026: 64 reportsAug 2026: 54 reportsSep 2026: 30 reportsOct 2026: 0 reports202420252026284
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate2,326
  • Loss of Osseointegration380
  • Osseointegration Problem124
  • Adverse Event Without Identified Device or Use Problem35
  • Fracture18
  • Migration13
  • Patient Device Interaction Problem13
  • Insufficient Device Problem Information5

Patient problems

  • Failure of Implant1,776
  • No Clinical Signs, Symptoms or Conditions838
  • Unspecified Infection378
  • Pain228
  • Inflammation55
  • Numbness55
  • Implant Pain40
  • Abscess32

Recent adverse event reports

The 25 most recent of 2,944 reports, in the reporter's own words as published by the FDA.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.