NobelReplace® 37291 (UDI 07332747073584)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 4.3x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is placed in the jaw. Its 715 reports, with 709 injuries and no deaths, mostly describe the implant failing to fuse with the jawbone or losing that bond, with some mentioning pain, infection and numbness. There is 1 recall, now closed, which began in July 2020 and concerns an implant cap label that may show the wrong size, which could lead to a second surgery or implant replacement.
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
- 715
- Deaths reported
- 0
- Injuries reported
- 709
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 715 adverse event reports that list this exact device (DI 07332747073584), received between Sep 11, 2019 and Jul 1, 2026 — classified as 709 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (344 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jul 20, 2020Terminated
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
Z-2828-2020 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate344
- Loss of Osseointegration326
- Osseointegration Problem18
- Fracture16
- Adverse Event Without Identified Device or Use Problem7
- Premature Separation3
- Insufficient Device Problem Information1
- Material Deformation1
Patient problems
- Failure of Implant683
- Pain119
- Unspecified Infection76
- No Clinical Signs, Symptoms or Conditions24
- Numbness12
- Implant Pain2
- Inflammation2
- Abscess1
Recent adverse event reports
The 25 most recent of 715 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25684186 ↗InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25684183 ↗InjuryJun 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646669 ↗InjuryJun 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646667 ↗InjuryMay 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129862 ↗InjuryMay 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129170 ↗InjuryMay 3, 2026Loss of Osseointegration
InjuryMay 3, 2026Loss of Osseointegration
InjuryJan 29, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24216405 ↗InjuryJan 29, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24216398 ↗InjuryJan 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24194976 ↗InjuryJan 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24194972 ↗InjuryJan 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23940345 ↗InjuryJan 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23940339 ↗InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23661721 ↗InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23661209 ↗InjuryNov 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23506061 ↗InjuryNov 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23506058 ↗InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22695152 ↗InjuryAug 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22695151 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22617037 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22617036 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.