Fine Osteotomy system - Distal femur 015-330-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00688346002140), received between Nov 14, 2022 and Oct 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Material Fragmentation; No Apparent Adverse Event; Migration; Material Fragmentation; No Apparent Adverse Event; Migration

  THE PATIENT UNDERWENT A LATERAL OPENING WEDGE DISTAL FEMUR OSTEOTOMY (DFO) TO ADDRESS A VALGUS DEFORMITY AROUND THE KNEE. ADDITIONALLY, THE PATIENT RECEIVED A LATERAL FEMORAL CONDYLE OSTEOCHONDRAL ALLOGRAFT. THE DFO PROCEDURE WAS PERFORMED IN THE STANDARD MANNER, AND ALTHOUGH THE MEDIAL HINGE CRACKED, IT WAS NOT STABILIZED. THE DFO OSTEOTOMY WAS SECURED WITH A BODYCAD PERSONALIZED PLATE, AND THE GAP WAS FILLED WITH A BONE GRAFT. THE INITIAL POST-OPERATIVE X-RAY SHOWED THAT THE PLATE WAS WELL-POSITIONED, AND THE SCREWS WERE OF THE APPROPRIATE LENGTH AS PLANNED.THE PATIENT RETURNED FOR A ROUTINE CHECKUP SIX WEEKS POST-OP, WHERE IT WAS NOTED THAT ONE OF THE DISTAL SCREWS (D) HAD SLIGHTLY BACKED OUT, AND ANOTHER SCREW (B) WAS SLIGHTLY BENT. HOWEVER, THE PLATE REMAINED STABLE, AND THE MICRO-FRACTURE AT THE HINGE SITE WAS SHOWING GOOD CONSOLIDATION. THERE WAS EXCELLENT BONE HEALING AND PROPER CONSOLIDATION OF THE OSTEOTOMY, WITH NO LOSS OF CORRECTION.AT THE SECOND ROUTINE CHECKUP, 12 WEEKS POST-OP, NO SIGNS OF INFECTION WERE OBSERVED. TWO SCREWS (C AND D) HAD BACKED OUT SLIGHTLY BUT REMAINED STABLE AND HAD NOT MOVED BEYOND THE LOCKING MECHANISM (3 MM). ALL OTHER SCREWS' THREADS WERE WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950052 ↗
• MalfunctionNov 14, 2022Migration; Migration

  SCREWS BACKING UP. DURING A ROUTINE APPOINTMENT, THE DOCTOR NOTICED ON THE X-RAY THAT 3 SCREWS WERE MIGRATING. NO INFECTION IS PRESENT. NOTE ALSO THAT WE SEE A FRACTURE ON THE OPPOSITE SIDE OF THE CORTEX. WE SEE A SMALL FRACTURE INITIATION ON THE POST-OP PHOTO AND IT SEEMS TO HAVE WORSENED ON THE 6 WEEK POST-OP PHOTO.

  Patient problems: Bone Fracture(s)

  MAUDE report 15792648 ↗