LEVEL ONE ORTHOANCHOR 50-340-11-09Recalls & reported problems
KLS-Martin L.P. · SCREW, CROSSDRIVE, DRILL FREE, 1.5 MM TISSUE COLLAR, TI-6AL-4V · Class 2 · Implant
All models of LEVEL ONE ORTHOANCHOR (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888118075413), received between Jun 30, 2017 and Jun 30, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2017Material Fragmentation; Material Fragmentation
RECEIVED MEDWATCH REPORT NO. (B)(4) FROM THE FACILITY. IT WAS REPORTED "ONE OF THE TEMPORARY ANCHORAGE DEVICES SHEARED OFF ON THE LOWER JAW, LEAVING BEHIND A TITANIUM SCREW. THIS WAS INTENTIONALLY LEFT BEHIND, RETRIEVING IT WOULD BE DETRIMENTAL TO THE PATIENT."
Patient problems: Foreign Body In Patient
MAUDE report 6682060 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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