HOFFMANN 4935-0-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327294231), received between Jul 2, 2018 and Jul 2, 2018 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K163656, K233741); 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2018Break; Component Falling

  UPON A FOLLOW-UP VISIT, 3 OF 6 HEXAPOD STRUTS WERE FOUND TO HAVE FAILED. THE PINS THAT HOLD THE STRUT AT THE HINGE WERE BROKEN. ALL 6 STRUTS WERE PULLED AND REPLACED. REP INDICATED THAT THE PINS WEREN¿T BROKEN. THEY FELL OUT. THEY FELL COMPLETELY OUT OF ONE STRUT, AND HALFWAY OUT OF THE OTHER TWO.

  Patient problems: Failure of Implant

  MAUDE report 7656724 ↗
• InjuryJul 2, 2018Detachment Of Device Component; Defective Component

  UPON A FOLLOW-UP VISIT, 3 OF 6 HEXAPOD STRUTS WERE FOUND TO HAVE FAILED. THE PINS THAT HOLD THE STRUT AT THE HINGE WERE BROKEN. ALL 6 STRUTS WERE PULLED AND REPLACED. REP INDICATED THAT THE PINS WEREN¿T BROKEN. THEY FELL OUT. THEY FELL COMPLETELY OUT OF ONE STRUT, AND HALFWAY OUT OF THE OTHER TWO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7656657 ↗
• InjuryJul 2, 2018Break; Component Falling

  UPON A FOLLOW-UP VISIT, 3 OF 6 HEXAPOD STRUTS WERE FOUND TO HAVE FAILED. THE PINS THAT HOLD THE STRUT AT THE HINGE WERE BROKEN. ALL 6 STRUTS WERE PULLED AND REPLACED. REP INDICATED THAT THE PINS WEREN¿T BROKEN. THEY FELL OUT. THEY FELL COMPLETELY OUT OF ONE STRUT, AND HALFWAY OUT OF THE OTHER TWO.

  Patient problems: No Information

  MAUDE report 7656646 ↗
• InjuryJul 2, 2018Break; Component Falling

  UPON A FOLLOW-UP VISIT, 3 OF 6 HEXAPOD STRUTS WERE FOUND TO HAVE FAILED. THE PINS THAT HOLD THE STRUT AT THE HINGE WERE BROKEN. ALL 6 STRUTS WERE PULLED AND REPLACED. REP INDICATED THAT THE PINS WEREN¿T BROKEN. THEY FELL OUT. THEY FELL COMPLETELY OUT OF ONE STRUT, AND HALFWAY OUT OF THE OTHER TWO.

  Patient problems: Failure of Implant

  MAUDE report 7656589 ↗
• InjuryJul 2, 2018Break; Component Falling

  UPON A FOLLOW-UP VISIT, 3 OF 6 HEXAPOD STRUTS WERE FOUND TO HAVE FAILED. THE PINS THAT HOLD THE STRUT AT THE HINGE WERE BROKEN. ALL 6 STRUTS WERE PULLED AND REPLACED. REP INDICATED THAT THE PINS WEREN¿T BROKEN. THEY FELL OUT. THEY FELL COMPLETELY OUT OF ONE STRUT, AND HALFWAY OUT OF THE OTHER TWO.

  Patient problems: No Code Available

  MAUDE report 7656575 ↗
• InjuryJul 2, 2018Detachment Of Device Component; Device Inoperable

  UPON A FOLLOW-UP VISIT, 3 OF 6 HEXAPOD STRUTS WERE FOUND TO HAVE FAILED. THE PINS THAT HOLD THE STRUT AT THE HINGE WERE BROKEN. ALL 6 STRUTS WERE PULLED AND REPLACED. REP INDICATED THAT THE PINS WEREN¿T BROKEN. THEY FELL OUT. THEY FELL COMPLETELY OUT OF ONE STRUT, AND HALFWAY OUT OF THE OTHER TWO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7656172 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163656, K233741. One submission often covers many models, so check the product and lot details in each record.

• Z-0288-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0291-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0290-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-0289-2019 · Aug 28, 2018 · Terminated
  Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment
• Z-3240-2018 · Jul 26, 2018 · Terminated
  Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002