NobelReplace® 36897Recalls & reported problems
Nobel Biocare AB · NobelReplace PS RP 5.0x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a root-form implant placed into bone. Of its 165 adverse event reports, 164 are injuries and 1 is a malfunction, with no deaths. Most describe the implant losing its bond with the bone or never bonding with it, and patients report implant failure, infection and pain. Reports rose from 23 in the prior 12 months to 52 in the last 12 months. 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
- 167
- Deaths reported
- 0
- Injuries reported
- 166
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 07332747034080), received between Sep 12, 2019 and Sep 30, 2026 — classified as 166 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (137 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
Most reported problems
Device problems
- Loss of Osseointegration137
- Failure to Osseointegrate16
- Adverse Event Without Identified Device or Use Problem4
- Osseointegration Problem4
- Corroded2
- Insufficient Device Problem Information2
- Migration2
Patient problems
- Failure of Implant98
- No Clinical Signs, Symptoms or Conditions37
- Unspecified Infection30
- Pain12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Abscess2
- Fistula2
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 167 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954100 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954098 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487077 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487076 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215295 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215293 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167236 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167235 ↗InjuryJul 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772465 ↗InjuryJul 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772431 ↗InjuryJul 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711905 ↗InjuryJul 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711901 ↗InjuryJun 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25643799 ↗InjuryJun 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25643798 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479269 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479268 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479214 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479208 ↗InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 27, 2026Loss of Osseointegration
InjuryApr 27, 2026Loss of Osseointegration
InjuryApr 14, 2026Loss of Osseointegration
InjuryApr 14, 2026Loss of Osseointegration
InjuryApr 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783851 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.