DS Implants 68010005 (UDI 07392532277160)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Cover Screw EV (M) · Class 2 · Implant
- 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 07392532277160), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Separation Failure1
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.
MalfunctionJan 6, 2026Separation Failure
IT WAS REPORTED THAT THE COVER SCREW COULD NOT BE REMOVED WHICH LED TO THE EXPLANTATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 23977727 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.