Cerclage Button 3.5T MDS110302CRecalls & reported problems
Miami Device Solutions LLC · Cerclage Button 3.5T · Class 2
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 10812269023150), received between Mar 22, 2021 and Mar 22, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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 18, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 22, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THE PATIENT HAD IRRITATION ON HIS SHOULDER, AND THE SUBJECT REVISION SURGERY HAD LESS TO DO WITH HARDWARE AND MORE TO DO WITH SOFT TISSUE EVALUATION. DURING THE SOFT TISSUE (NERVE) EVALUATION THE SURGEON DECIDED TO REMOVE TWO CERCLAGE BUTTONS (PART#: MDS110302C LOT#: 116464) AND CERCLAGE WIRE (UNKNOWN MANUFACTURER, UNKNOWN PART NUMBER, UNKNOWN, LOT NUMBER). THE ITEMS WERE REPLACED WITH TWO SCREWS AND TWO LOCKING CAPS. THERE WERE NO REPORTED DELAYS TO THE PROCEDURE AND NO IMPACT TO THE PATIENT'S OUTCOME AS A RESULT OF THE REVISION SURGERY. PRODUCT WILL NOT BE RETURNED.
Patient problems: Implant Pain
MAUDE report 11544253 ↗
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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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