MicroAire® 22102Recalls & reported problems
Microaire Surgical Instruments LLC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847399006851), received between Feb 19, 2021 and May 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Fracture
CUSTOMER STATES RIGHT BROW DROPPED SEVERAL DAYS AFTER SURGERY ON (B)(6) 2026. A SECOND SURGERY TO REPLACE ENDOTINE WAS DONE ON (B)(6) 2026.
Patient problems: Inadequate Osseointegration
MAUDE report 25304420 ↗MalfunctionFeb 19, 2021Loss of Osseointegration; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth
ENDOTINE FOREHEAD 3.5 LOT 3 351185 WAS PLACED ON (B)(6) 2022 DID NOT HOLD THE SOFT TISSUE SECURELY AND TIGHTLY. DOCOTR FOUND THAT THE IMPLANT DID NOT HOLD THE SOFT TISSUE SECURELY. IT MEANT THAT THE FIXATION WAS LOOSE AND PATIENT REQUESTED A RE-DO PROCEDURE AND IMPLANTED ANOTHER 22102 LOT # 354742 ON (B)(6) 2021 AND THE OPERATION WAS DONE SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11350576 ↗
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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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