LEPORELLO 3.5mm Olecranon Plate, 9 Hole, Left B-151100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640187461954), received between Sep 6, 2024 and Nov 10, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 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.

• InjuryNov 10, 2025Fracture; Fracture

  ON (B)(6) 2025, BONEBRIDGE RECEIVED A REPORT FROM THE (B)(6) HOSPITAL (AUSTRALIA) CONCERNING A BREAKAGE OF A LEPORELLO 3.5 MM OLECRANON PLATE, WHICH OCCURRED FOUR WEEKS POST-IMPLANTATION. THE PLATE HAD BEEN USED TO STABILIZE A PERIPROSTHETIC ELBOW FRACTURE IN A PATIENT WITH AN EXISTING ELBOW PROSTHESIS. ACCORDING TO THE SURGEON, NO TRAUMA OR EXTERNAL EVENT PRECEDED THE PLATE BREAKAGE. REVISION SURGERY ON (B)(6) 2025 CONFIRMED PLATE FRACTURE AT THE PROXIMAL SUTURE HOLES. RADIOGRAPHIC IMAGES PROVIDED FOR INVESTIGATION SHOW THAT THE IMPLANT HAD BEEN EXTENSIVELY MODIFIED INTRAOPERATIVELY. THE ORIGINAL 90° OLECRANON ANGLE OF THE PLATE WAS BENT INTO AN ALMOST FLAT CONFIGURATION, RESULTING IN A QUASI-STRAIGHT PLATE. THIS ADAPTATION SUBSTANTIALLY ALTERED THE INTENDED GEOMETRY AND MECHANICAL PERFORMANCE OF THE IMPLANT. GIVEN THE MAGNITUDE OF DEFORMATION APPLIED INTRAOPERATIVELY, A PRIOR WEAKENING OF THE PLATE CANNOT BE COMPLETELY RULED OUT. DUE TO THE COMMINUTED FRACTURE PATTERN AND THE RESULTING LONG BRIDGING SPAN, COMBINED WITH THE VERY DISTAL PLATE PLACEMENT (FOLLOWING THE SHAPE MODIFICATION), BENDING FORCES WERE CONCENTRATED AROUND THE SUTURE HOLE. IF A SCREW HOLE HAD BEEN LOCATED AT TH

  Patient problems: Limb Fracture

  MAUDE report 23513672 ↗
• InjurySep 6, 2024Material Integrity Problem; Material Integrity Problem

  ON AUGUST 8, 2024, BONEBRIDGE WAS NOTIFIED ABOUT A BREAKAGE OF A LEPORELLO 3.5MM OLECRANON PLATE THAT OCCURED IN SWITZERLAND. THE CASE INVOLVED A 55-YEAR-OLD FEMALE PATIENT WITH BILATERAL TRAUMATIC ELBOW DISLOCATION. THE PATIENT HAD A HIGHLY COMMINUTED OLECRANON FRACTURE ON THE LEFT SIDE, WHICH WAS TREATED WITH A LEPORELLO 3.5MM OLECRANON PLATE, AND A CORONOID FRACTURE ON THE RIGHT SIDE. THE SURGERY TOOK PLACE ON (B)(6) AND WAS REPORTED AS UNEVENTFUL. SEVEN WEEKS LATER, DURING THE FIRST POSTOPERATIVE VISIT, THE X-RAY REVEALED A PLATE BREAKAGE AT THE COMMINUTION ZONE. THE PATIENT REPORTED NO FALL OR OTHER INCIDENT THAT COULD HAVE CAUSED THE BREAKAGE. HOWEVER, THE PATIENT REPORTED DAILY HOUSEHOLD ACTIVITIES, INLCUDING USING HER ARM TO HELP HER HUSBAND PUT ON SUPPORT STOCKINGS. THE X-RAYS WERE PROVIDED TO BONEBRIDGE. DUE TO CONCERNS ABOUT THE FIXATION TECHNIQUE, THE CASE WAS REVIEWED INDEPENDENTLY BY TWO ORTHOPEDIC SURGEONS FROM THE BONEBRIDGE TECHNICAL COMMISSION. THE ORIGIN OF THE CASE WAS BLINDED TO THE REVIEWERS, AND THEY PROVIDED ORAL FEEDBACK TO BONEBRIDGE CEO DR. (B)(6). REVIEWER 1 OBSERVED THAT THE FRACTURE ZONE WAS NOT COMPRESSED AND THE CORONOID FRAGMENT WAS NOT PROPERLY STA

  Patient problems: Limb Fracture

  MAUDE report 20156591 ↗