MIS CS-HS348Recalls & reported problems
MIS Implants Technologies Ltd. · Healing cap Ø4.8x3mm coni. con., SP · 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 07290108996630), received between May 26, 2026 and May 26, 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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Separation Failure
IT WAS REPORTED THAT THE HEALING SCREW WAS FIRMLY LODGED IN PLACE AND COULD NOT BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25285130 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.