NA 393.745Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982199386), received between Sep 15, 2020 and Sep 15, 2020 — classified as 1 injury.

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 18, 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.

• InjurySep 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE ORTHOKIT SET WASN'T COMPATIBLE FOR THE SURGERY AS EXPECTED. THE DESCRIPTION OF THE SET DID NOT ALIGN WITH THE OPERATING TECHNIQUE. THE PATIENT WAS ALREADY IN NARCOSIS AND PREPARED FOR SURGERY BUT HAD TO BE WAKEN UP WITHOUT ANY INTERVENTION. THEREFORE PATIENT IS STILL WAITING FOR TREATMENT. ON (B)(6) 2020 IT WAS DETERMINED THAT THEORTHOKIT USED IS NAMED "HYBRID RING FIXATOR SET". CHANGES WERE MADE TO THE ORTHOKIT BECAUSE THE HIBRID RING FIXATOR ARTICLES ARE OBSOLETE HOWEVER, NO COMMUNICATION WAS MADE IN TERMS OF THE ARTICLES BEING OBSOLETE AND ABOUT THE CHANGES IN THE ORTHOKIT. THE ARTICLES IN THE ORTHOKIT AS IT IS NOW, HAVE NOTHING TO DO WITH THE HYBRID-RING-FIXATOR, EXCEPT THE PARTS FOR THE LARGE EXTERNAL FIXATOR. THEY ARE PART OF THE DISTRACTOR OSTEOGENESIS. THE ARTICLES ARE OBSOLETE AND IT ISN¿T POSSIBLE TO DO A HYBRID-RING FIXATOR SURGERY ANYMORE. THIS REPORT IS FOR ONE (1) SPLIT TISSUE PROTECTION SLEEVE 2.5MM. THIS IS REPORT 1 OF 6 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: No Code Available

  MAUDE report 10538403 ↗