CASCELLA 3.5mm Superior Clavicle Plate, Lateral, 9 Hole, Right B-132010Recalls & reported problems
Bonebridge AG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640187461756), received between Jul 4, 2025 and Jul 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Limb Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 2025Material Integrity Problem; Material Integrity Problem
ON 13 JUNE 2025, BONEBRIDGE WAS INFORMED BY DR. (B)(6), OF A PLATE BREAKAGE IN A PATIENT TREATED WITH THE CASCELLA LATERAL CLAVICLE PLATE. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2025. THE IMPLANT BROKE APPROXIMATELY THREE WEEKS POSTOPERATIVELY WITHOUT ANY REPORTED EXTERNAL TRAUMA. REVISION SURGERY WAS SUCCESSFULLY COMPLETED ON (B)(6) 2025 WITHOUT COMPLICATIONS. THE FRACTURE WAS A COMMINUTED LATERAL CLAVICLE FRACTURE WITH MULTIPLE FRAGMENTS AND PARTIAL BONE LOSS. TO ACHIEVE STABILIZATION, THE SURGEON APPLIED THE CASCELLA PLATE IN A BRIDGING CONFIGURATION [?] SPANNING AN AREA OF THE CLAVICLE THAT LACKED DIRECT BONY SUPPORT. ADDITIONALLY, THE FRACTURE ZONE WAS STABILIZED INTRAOPERATIVELY WITH A VICRYL CERCLAGE TO MAINTAIN FRAGMENT ALIGNMENT. WHILE THIS MEASURE CAN HELP WITH EARLY FRAGMENT POSITIONING, IT DOES NOT PROVIDE SIGNIFICANT MECHANICAL OFFLOADING OF THE IMPLANT. AS A RESULT, THE PLATE BORE MOST OF THE LOAD DURING THE EARLY HEALING PHASE. BONEBRIDGE RE-ASSESSED ALL RELEVANT CLINICAL AND TECHNICAL FACTORS: THE IMPLANT WAS MANUFACTURED ACCORDING TO VALIDATED PROCESSES, PASSED ALL INSPECTIONS, AND MET ALL SPECIFICATIONS. DESIGN VALIDATION TESTING CONFIRMED FATIGUE RESISTANCE
Patient problems: Limb Fracture
MAUDE report 22402894 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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