NA 394.071Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982199539), received between Jan 16, 2019 and Jul 11, 2023 — classified as 2 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJul 11, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 AN UNKNOWN REVISION PROCEDURE WAS BEING PERFORMED ON THE PATIENT. DURING THE SURGERY, IT WAS DISCOVERED THAT THE MINI LENGTHENING DEVICE THAT WAS IMPLANTED FOR DISTRACTION 6 MONTHS AGO HAD LOOSENED. THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MINI LENGTHENING APPARATUS 110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17297288 ↗
• InjuryOct 18, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT PUT OUR MINI LENGTHENING APPARATUS ON AND IT BROKE. THE PATIENT WAS COMING IN FOR MORE X-RAYS AND NEW APPARATUS APPLICATION. THE X-RAYS REVEALED THAT THE APPARATUS WAS OVER DISTRACTED DUE TO THE FACT THAT THE PIN PLACEMENT DEVICE WAS NOT TIGHTENED DOWN CAUSING IT TO SLIDE DOWN THE BARREL. THIS REPORT IS FOR ONE (1) MINI LENGTHENING APPARATUS 110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9207175 ↗
• MalfunctionJan 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A METATARSAL OSTEOTOMY PROCEDURE ON (B)(6) 2018, THE TURNING WHEEL AND SCREW FOR THE MINI LENGTHENING APPARATUS FELL OFF WHILE THE PATIENT WAS AT HOME WITH THE DEVICE. ANOTHER WHEEL AND SCREW WERE PROVIDED AND PLACED ON THE EXISTING DEVICE. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A MINI LENGTHENING APPARATUS 110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254301 ↗