proGAV 2.0® FX525TRecalls & reported problems
Christoph Miethke GmbH & Co. KG · PROGAV 2.0 SYSTEM · Class 2 · Implant
All models of proGAV 2.0 (49)
Data updated Oct 16, 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 04041906136734), received between Sep 5, 2024 and Sep 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement1
Patient problems
- Dizziness1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV DEVICE (PART# UNKNOWN) WAS IMPLANTED DURING A REVISION PROCEDURE SOMETIME IN 2016. ACCORDING TO THE COMPLAINANT THE LAST TIME THE DEVICE ADJUSTED WAS IN 2018. ADDITIONALLY THE LAST MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AROUND THE SAME TIME. REPORTEDLY SINCE THE LAST ADJUSTMENT THE INSTRUMENT HAS BEEN ADJUSTING ITSELF. THE PATIENT HAS REPORTED BAD PROBLEMS WITH BALANCE AND COORDINATION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC 100036844 CC 400672564.
Patient problems: Dizziness; Pain
MAUDE report 20144060 ↗
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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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