MAUDE Adverse Event Report: NOVASTEP SAS CENTROLOCK; IMPLANT CENTROLOCK LEFT STEP 4

Catalog Number	PL070204
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Implant Pain (4561); Insufficient Information (4580)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In summary, the implementation of the device took place on (b)(6) 2025, in france.After six months, on (b)(6) 2025, a potential device issue was suspected.This issue was confirmed on (b)(6) 2025, through x-ray imaging.We received this information on november 25, 2025.The surgeon reported that the healing process is progressing appropriately and plans to continue monitoring the patient throughout 2026.Additionnal investigation may be concidered on similar devices, in case of explantation on the consent device itself.
Event or Problem Description
This event took place in france, novastep have been informed of this case on the 11/25/2025.Breakage of the implant post op.Device implanted on (b)(6) 2025.At 6 months post implantation, on (b)(6) 2025, a device problem was suspected during a scanner performed as the patient reported unusual pain.The problem was confirmed on (b)(6) 2025 by performing x-rays.It reveals that the implant has broken.Consequence: as reported by the surgeon "as far as treatment is concerned, it remains relatively painless for the moment and bone callus is gradually forming at the osteotomy site with good correction of the foot." the surgeon has therefore authorized her to gradually resume wearing normal shoes with rigid soles.He plans to monitor the patient in (b)(6) 2026.

• Brand Name: CENTROLOCK
• Common Device Name: IMPLANT CENTROLOCK LEFT STEP 4
• Manufacturer (Section D): NOVASTEP SAS; 2 all jacques frimot; rennes, 35000 ; FR 35000
• Manufacturer Contact: patrick lebas ; 2 all jacques frimot,; rennes, 35000 ; FR 35000
• MDR Report Key: 23932540
• Report Number: 3010673777-2025-00041
• Device Sequence Number: 5610105
• Product Code: HRS
• UDI-Device Identifier: 03700879511849
• UDI-Public: 03700879511849
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/31/2025

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
• Device Catalogue Number: PL070204
• Device Lot Number: K03252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female