NobelReplace® 37293 (UDI 07332747073560)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 4.3x13mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant is placed in the jawbone to hold a replacement tooth. Of its 355 reports, 354 are injuries and 1 is a malfunction, with no deaths. Most describe the implant losing or failing to fuse with the bone, and many mention pain or infection. Reports rose to 28 in the last 12 months from 14 before that, and there are no recalls naming 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
- 355
- Deaths reported
- 0
- Injuries reported
- 354
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 07332747073560), received between Sep 11, 2019 and Jul 27, 2026 — classified as 354 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (169 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 Osseointegration169
- Failure to Osseointegrate166
- Osseointegration Problem14
- Adverse Event Without Identified Device or Use Problem3
- Fracture3
- Difficult to Insert1
Patient problems
- Failure of Implant317
- Pain55
- Unspecified Infection53
- No Clinical Signs, Symptoms or Conditions16
- Abscess5
- Numbness5
- Bone Fracture(s)2
Recent adverse event reports
The 25 most recent of 355 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384303 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384299 ↗InjuryApr 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889942 ↗InjuryApr 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889941 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836150 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836149 ↗InjuryApr 8, 2026Failure to Osseointegrate
InjuryApr 8, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 30, 2026Failure to Osseointegrate
InjuryMar 25, 2026Loss of Osseointegration
InjuryMar 25, 2026Loss of Osseointegration
InjuryMar 24, 2026Loss of Osseointegration
InjuryMar 24, 2026Loss of Osseointegration
InjuryMar 2, 2026Failure to Osseointegrate
InjuryMar 2, 2026Failure to Osseointegrate
InjuryDec 17, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833472 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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