MAUDE Adverse Event Report: BONEBRIDGE AG CASCELLA; CASCELLA 3.5MM SUPERIOR CLAVICLE SYSTEM

Model Number	CASCELLA 3.5MM SUPERIOR C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The failure occurred within the expected mechanical limitations of the plate under high loading conditions.There is therefore no indication of a systemic issue with the implant.The device met all specifications.
Event or Problem Description
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 up to 263 n for 900,000 cycles, exceeding the predicate device synthes lcp superior clavicle plate 3.5 mm, which withstood 250 n under identical test conditions.A post-market clinical follow-up (pmcf) study was conducted in europe (in accordance with european regulatory requirements).The study included 194 patients and showed no similar cases of plate breakage and a bone healing rate of (b)(4).Additionally, scientific literature supports that while plate breakage in clavicle fixation is rare, it is more likely in bridging constructs[?]especially in cases with limited bony contact.Furthermore, breakage rates reported in the literature for comparable implants range from 2.7% to 7.5%.In contrast, the cascella lateral plate has shown a complication rate of (b)(4) in current surveillance.In conclusion, based on the case-specific information provided to bonebridge and the investigation performed, the implant breakage is attributed to a mechanically demanding clinical environment, including: a long unsupported plate span due to the comminuted fracture, local stress concentration from nearby k-wire drill holes, fatigue stress from normal postoperative shoulder movement.Limited mechanical reinforcement from the vicryl cerclage, which does not significantly offload the plate.The failure occurred within the expected mechanical limitations of the implant under high loading conditions.There is therefore no indication of a systemic issue with the device.The device met all specifications.

• Brand Name: CASCELLA
• Common Device Name: CASCELLA 3.5MM SUPERIOR CLAVICLE SYSTEM
• Manufacturer (Section D): BONEBRIDGE AG; bahnhofstrass 11,; zug, 6300 ; SZ 6300
• Manufacturer (Section G): BONEBRIDGE AG; bahnhofstrass 11; zug, 6300 ; SZ 6300
• Manufacturer Contact: michelle gumpelmayer ; bahnhofstrass 11; zug, 6300 ; SZ 6300
• MDR Report Key: 22402894
• Report Number: 3021010222-2025-00704
• Device Sequence Number: 9978013
• Product Code: HRS
• UDI-Device Identifier: 07640187461756
• UDI-Public: 07640187461756
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K213864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CASCELLA 3.5MM SUPERIOR C
• Device Catalogue Number: B-132010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG