NobelReplace® 36707 (UDI 07332747160529)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 4.3x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant has 4,057 adverse event reports, with no deaths and 3,984 injuries. The reports mostly describe implants that fail to fuse with the jawbone or later lose that hold, plus infection and pain. The 1 recall, now closed, began in December 2021 when surgical drivers failed to engage some implants, which could delay surgery.
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
- 4,083
- Deaths reported
- 0
- Injuries reported
- 4,010
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,083 adverse event reports that list this exact device (DI 07332747160529), received between Oct 29, 2021 and Sep 29, 2026 — classified as 4,010 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,829 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
- Dec 17, 2021Terminated
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Z-0658-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate2,829
- Loss of Osseointegration766
- Osseointegration Problem227
- Adverse Event Without Identified Device or Use Problem89
- Patient Device Interaction Problem39
- Fracture34
- Material Deformation22
- Migration20
Patient problems
- Failure of Implant2,646
- No Clinical Signs, Symptoms or Conditions1,066
- Unspecified Infection364
- Pain275
- Abscess60
- Inflammation45
- Numbness40
- Implant Pain38
Recent adverse event reports
The 25 most recent of 4,083 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940571 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940567 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924888 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924887 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924791 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924787 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924784 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924783 ↗InjurySep 19, 2026Fracture
Patient problems: Abscess
MAUDE report 50833594 ↗InjurySep 19, 2026Fracture
Patient problems: Abscess
MAUDE report 50833590 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833199 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833198 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829805 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829804 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796140 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796124 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764538 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764523 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749086 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749082 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748928 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748926 ↗InjurySep 14, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748174 ↗InjurySep 14, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748171 ↗InjurySep 14, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748167 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.