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

Model Number	PL070104
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Arthralgia (2355); Impaired Healing (2378); Malunion of Bone (4529)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product remained implanted.Batch record reviewed: no root cause identified from the manufacturing process.X-rays retrieved: suggests a misalignment of the bone fragments no correction or clinical outputs mentioned from the surgeon's side.Product initially remained implanted, but finally removed on (b)(6) 2026.Decision taken on (b)(6) 2025: the delay is due to the decision of the healthcare professional to wait for the 6-month recovery period before assessing the success of the bone recovery.According to the surgeon, the patient does not show any prior risk of failure and has followed the recovery instructions.On our side, we inspected 3 parts from the same implant batch with internal control means and confirmed their conformity to our geometrical specifications.Additional lab investigations have been performed on another explanted device from the same batch number, involved in a similar incident fda report: 3010673777-2025-00004, and in comparison, with one non-used device of the same batch number.Shipped for analysis on dec.17 to critt lab, for in-depth analysis of the material and the breakage profile, and by comparison to a not-used device of the same batch number.Following testing performed: chemical analysis testing: /cp and combustion examination of the fracture surface using a binocular microscope and sem microscopic examination vickers full-depth hardness testing.Conclusion of the analysis - as stated in the critt report n°25.12.150, dated 24/02/2026: the fracture of the centrolock implant is not due to poor-quality raw materials in terms of chemical composition, microstructure, or hardness.The fracture is caused by implant fatigue, potentially due to excessive and abnormal bending.Thus, the conclusions relative to raw material applies to the device in cause here.In addition, the explant has been retrieved on may 4th: the breakage profile is also typical of a fatigue breakage.Thus, considering the similarities between this case and the r2532614 one, we can assume that the cause of fracture is likely to be the same.
Event or Problem Description
During the follow-up x-ray at t+6 weeks after implantation, the surgeon observed that the implant has broken since its implantation.Case: transverse osteotomy for bunion correction.Consequence: correction not stable - potential delay for recovery, and potential need of an additional surgical procedure for correction.The surgeon decided to maintain the implants in the patient as the bone healing was going on then on (b)(6) 2025: the surgeon informed that he planned to remove the implant on (b)(6) 2026, and on (b)(6) 2026: revision surgery performed, centrolock explanted and replaced by peca screws.The device was retrieved on april 30th 2026 and shipped to hq on may 4th 2026.

• Brand Name: CENTROLOCK
• Common Device Name: IMPLANT CENTROLOCK DROIT STEP 4
• Manufacturer (Section D): NOVASTEP SAS; 2 all jacques frimot, 35000; rennes 35000; rennes, france 35000 ; FR 35000
• Manufacturer Contact: patrick lebas lebas ; 2 all jacques frimot, 35000 rennes; rennes, 35000 ; FR 35000
• MDR Report Key: 25357998
• Report Number: 3010673777-2025-00003
• Device Sequence Number: 10613045
• Product Code: HRS
• UDI-Device Identifier: 03700879511870
• UDI-Public: 03700879511870
• 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
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PL070104
• Device Lot Number: L20966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2024
• 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 Sex: Unknown