INSTRUMENT 6496-9-055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327198515), received between Jan 3, 2019 and Jan 3, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, FOR A PATIENT WHO WAS OPERATED SEVERAL TIMES BY THE SAME SURGEON, THE LAST SURGERY WAS THE SECOND FAILED ATTEMPT TO EXCHANGE THE GROWING PIECE OF HIS GMRS IMPLANT (HMRS/GMRS SPIGOT SEPARATOR). A LONGER GROWING PIECE IS NEEDED, GROWING PIECE THE PATIENT CURRENTLY HAS FAILED/LOST IT¿S ABILITY TO KEEP IT¿S FULL LENGTH. IT IS SUSPECTED THAT SEPARATION OF THE STEM/GROWING PIECE SPIGOT FAILED BECAUSE OF COLD FUSION. THE PATIENT (B)(6) BOY) HAS 6CM DIFFERENCE IN LEG LENGTH, THE ORIGINAL GROWING COMPONENT IS SET TO IT¿S MAXIMUM LENGTH BUT AS IT¿S COLLAPSED ONCE THE PATIENT¿S PARENTS LOST THEIR TRUST IN THE DEVICE. IT IS NOT CLEAR WHY/HOW THE DEVICE LOST IT¿S INTERNAL BLOCKAGE, BUT THE SURGEON FOUND IT COLLAPSED ( IN THE SHORTEST POSITION INSTEAD OF THE LAST SET ELONGATION ) IN THE OPERATION WHEN THEY WANTED TO DO THE LAST ADJUSTMENT ( THE LAST 5MM ) BEFORE CHANGING TO THE LONGER PIECE. AFTER THEY WENT THROUGH THE ELONGATION STEPS AGAIN - 2-3 SMALL SURGERIES - THEY REACHED FULL LENGTH AGAIN, THE DEVICE SHOWED NO SIGNS OF FAILURE/INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 8215314 ↗