HOFFMANN 4933-0-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327131475), received between Sep 17, 2019 and Sep 17, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2019Break; Detachment of Device or Device Component

  3 OUT OF 4 SAFETY CLIPS HAD POPPED OFF OF LRF BONE TRANSPORT STRUTS. THE PATIENT WAS ONLY LENGTHENING ON 1 OUT OF THE 4 TOTAL BONE TRANSPORT STRUTS FOR A POSSIBLE PERIOD OF 1 WEEK (THIS WAS THE AMOUNT OF TIME BETWEEN CLINIC VISITS). THIS MAY HAVE CAUSED PREMATURE CONSOLIDATION OF THE BONE REGENERATE THAT WAS BEING TRANSPORTED. THE SURGEON DECIDED TO REDO THE OSTEOTOMY. THIS WAS PERFORMED DURING AN ALREADY PLANNED DOCKING SITE PROCEDURE OF THE DISTAL SEGMENT. SAFETY CLIPS WERE PLACED BACK ON BONE TRANSPORT STRUTS IN THE CLINIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9079694 ↗
• InjurySep 17, 2019Device Slipped

  3 OUT OF 4 SAFETY CLIPS HAD POPPED OFF OF LRF BONE TRANSPORT STRUTS. THE PATIENT WAS ONLY LENGTHENING ON 1 OUT OF THE 4 TOTAL BONE TRANSPORT STRUTS FOR A POSSIBLE PERIOD OF 1 WEEK (THIS WAS THE AMOUNT OF TIME BETWEEN CLINIC VISITS). THIS MAY HAVE CAUSED PREMATURE CONSOLIDATION OF THE BONE REGENERATE THAT WAS BEING TRANSPORTED. THE SURGEON DECIDED TO REDO THE OSTEOTOMY. THIS WAS PERFORMED DURING AN ALREADY PLANNED DOCKING SITE PROCEDURE OF THE DISTAL SEGMENT. SAFETY CLIPS WERE PLACED BACK ON BONE TRANSPORT STRUTS IN THE CLINIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9079692 ↗
• InjurySep 17, 2019Unintended Ejection

  3 OUT OF 4 SAFETY CLIPS HAD POPPED OFF OF LRF BONE TRANSPORT STRUTS. THE PATIENT WAS ONLY LENGTHENING ON 1 OUT OF THE 4 TOTAL BONE TRANSPORT STRUTS FOR A POSSIBLE PERIOD OF 1 WEEK (THIS WAS THE AMOUNT OF TIME BETWEEN CLINIC VISITS). THIS MAY HAVE CAUSED PREMATURE CONSOLIDATION OF THE BONE REGENERATE THAT WAS BEING TRANSPORTED. THE SURGEON DECIDED TO REDO THE OSTEOTOMY. THIS WAS PERFORMED DURING AN ALREADY PLANNED DOCKING SITE PROCEDURE OF THE DISTAL SEGMENT. SAFETY CLIPS WERE PLACED BACK ON BONE TRANSPORT STRUTS IN THE CLINIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9079688 ↗