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NA 04.641.095Recalls & reported problems

Synthes GmbH · TI PROXIMAL EXTENSION SIZE 5/220MM RADIUS · Class 2 · Implant

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 10705034750392), received between Apr 1, 2019 and Apr 1, 2019 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Discomfort1
  • 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.

  • InjuryApr 1, 2019Break; Break

    04/23/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY FOR A FAILED VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) TITANIUM DISTAL EXTENSION, TITANIUM PROXIMAL EXTENSION AND TITANIUM DISTRACTION LOCK, THESE DEVICES HAVE BREAKAGE/FRACTURE. THE PATIENT PRESENTED WITH SOME DISCOMFORT. X-RAYS REVEALED SPLAYING OF THE RAILS OF THE PROXIMAL EXTENSION. THE PATIENT ALSO WAS ABOUT TO OUTGROW HIS EXTENSION ON THE CONTRA-LATERAL SIDE, SO SURGERY WAS SCHEDULE TO REPLACE BOTH SIDES. THERE WAS PATIENT CONSEQUENCE DUE TO MYELOMENIGOCELE. PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT EXPOSED TO ADDITIONAL ANESTHESIA FOR ONE (1) HOUR. CONCOMITANT DEVICE REPORTED: TI DISTRACTION LOCK (PART # 497.125, LOT # H468144, QUANTITY # 1) UNK - RODS: SPINE (PART # UNKNOWN, LOT # UNKNOWN # QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Patient problems: Discomfort; No Code Available

    MAUDE report 8470967 ↗

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 · Terminated
    VEPTR 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

All Prosthesis, rib replacement devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.