Hahn 70-1154-IMP0007Recalls & reported problems
Prismatik Dentalcraft, Inc · Hahn Tapered Implant 3.5 x 13 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D745701154IMP00070), received between May 17, 2018 and May 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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.
Most reported problems
Device problems
- Failure to Osseointegrate1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2018Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED TO OSSEOINTEGRATE. THE IMPLANT WAS BEING PLACED INTO THE TOOTH # 7. THE IMPLANT SITE HAS TYPE 4 BONE QUALITY. THERE WAS NO BONE LOSS. THE IMPLANT WAS NOT PLACE IN PREVIOUSLY GRAFTED SITE. THE IMPLANT SITE WAS NOT INFECTED. THE PATIENT HAS NO RELEVANT PRE-EXISTING CONDITION. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THERE WAS NO ABNORMALITY WITH THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 7524590 ↗
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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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