NobelReplace® 32163Recalls & reported problems
Nobel Biocare AB · NOBELREPLACE Straight Groovy NP 3.5x15mm · Class 2 · Implant
All models of NobelReplace (120)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07332747019032), received between Dec 22, 2021 and Sep 11, 2026 — classified as 14 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (12 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration12
- Fracture4
Patient problems
- Failure of Implant8
- Inflammation4
- Unspecified Infection4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743664 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743662 ↗InjuryDec 10, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 10, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 22, 2025Fracture; Fracture
MalfunctionOct 22, 2025Fracture; Fracture
MalfunctionOct 22, 2025Fracture; Fracture
InjuryOct 22, 2025Fracture; Fracture
InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13563126 ↗InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13563118 ↗InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13563066 ↗InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13563058 ↗InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13563047 ↗InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13562994 ↗InjuryDec 22, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13063232 ↗InjuryDec 22, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 13063219 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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