Paltop 20-70008PRecalls & reported problems
Paltop Advanced Dental Solutions Ltd · Advanced + Dental Implant Ø4.2mm L11.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Paltop dental implant is a root-form screw placed into the jawbone to support a replacement tooth. The 31 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that fusion after it had formed, with one report mentioning pain. No deaths were reported and all 31 reports involved injuries. There are no recalls naming this device. Reports of this problem rose sharply, from 4 in the previous 12 months to 27 in the most recent 12 months.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07290108695823), received between Oct 21, 2025 and Sep 7, 2026 — classified as 33 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (25 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate25
- Loss of Osseointegration8
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Inadequate Osseointegration7
- Pain1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50644954 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50644022 ↗InjuryAug 17, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50271698 ↗InjuryAug 16, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50265906 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151151 ↗InjuryAug 3, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111313 ↗InjuryAug 3, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111307 ↗InjuryJul 29, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50064843 ↗InjuryJun 23, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25591229 ↗InjuryMay 31, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344386 ↗InjuryMay 25, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267675 ↗InjuryMay 24, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266495 ↗InjuryMay 17, 2026Failure to Osseointegrate
InjuryMay 13, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25158958 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157360 ↗InjuryMay 11, 2026Failure to Osseointegrate
InjuryMay 10, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133277 ↗InjuryMay 7, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25109113 ↗InjuryApr 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994499 ↗InjuryApr 20, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24921765 ↗InjuryApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24893333 ↗InjuryMar 3, 2026Loss of Osseointegration
InjuryFeb 24, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24424954 ↗InjuryFeb 19, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24386438 ↗InjuryJan 13, 2026Loss of Osseointegration
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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