INTEGRA® 3610-06-2IRecalls & reported problems
Pmt Corporation · TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE, INTERNAL PORT · Class U · 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 00650551029069), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2025Deflation Problem; Deflation Problem
CUSTOMER HAS SENT PHOTOS AND VIDEOS OF A PEDIATRIC PATIENT WITH THIS EXPANDER IMPLANTED FOR AN EAR RECONSTRUCTION CASE. VIDEOS SHOW EXPANDER BEING FILLED, AND ONCE NEEDLE IS REMOVED, SALINE IMMEDIATELY SPRAYS OUT OF THE ENTRY POINT THROUGH THE PATIENT'S SKIN. NO EXPANSION IS HAPPENING BECAUSE OF THIS.
Patient problems: Insufficient Information
MAUDE report 21093300 ↗
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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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