NA 04.641.113Recalls & reported problems
Synthes GmbH · TI DISTAL EXTENSION SIZE 3/220MM RADIUS · Class 2 · Implant
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 10705034750484), received between Jul 16, 2018 and Jul 16, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K142587); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2018Break; Break
THE EVENT OCCURRED DURING A LENGTHENING OF THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) ROD PROCEDURE ON (B)(6) 2018. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 7689388 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142587. One submission often covers many models, so check the product and lot details in each record.
- Z-2488-2015 · Jul 29, 2015 · TerminatedVEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic de
Other Prosthesis, rib replacement devices
- NA 04.641.002Synthes GmbH · Prosthesis, rib replacement4 reports
- NA 04.641.056Synthes GmbH · Prosthesis, rib replacement1 report
- NA 04.641.115Synthes GmbH · Prosthesis, rib replacement1 report
- NA 04.641.095Synthes GmbH · Prosthesis, rib replacement1 report
- NA 04.641.117Synthes GmbH · Prosthesis, rib replacement1 report
- NA 497.125Synthes GmbH · Prosthesis, rib replacement1 report
- Response Rib and Pelvic System 00-1600-5000Orthopediatrics Corp. · Prosthesis, rib replacement1 report
- NA 04.641.057Synthes GmbH · Prosthesis, rib replacement1 report
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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