MAUDE Adverse Event Report: NOVASTEP SAS PECA® 2.0; BUNION IMPLANT Ø4 LG54/LG42

Model Number	PS060054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received, two peca2.0 screws were implanted and subsequently explanted from the patient after a certain period of time as mentionned in the report, then replaced due to patient noncompliance.The reporter could not provide any further information despite multiple follow-up attempts.
Event or Problem Description
We have received the information that a revision surgery took place on the (b)(6) 2026 to remove the peca screws (2 screws) due to patient noncompliance.Date of the first surgery is (b)(6) 2025, was completed successfully according to the reported; also the revision surgery was complited successfully and no defect was observed on the explanted devices.The revision consisted of replacing the screws with a lisfranc plate system.No further informations have been communicated.Two screws are mentioned in this report.Since section d allows only one reference to be entered, the full details of the products associated with this event are provided below : (b)(4): product refrence.Bunion implant ø4 lg54 : product name.(b)(4) : udi-di.M24865 : batch number.Expiry date : 04/01/2030.(b)(4): product refrence.Bunion implant ø4 lg42: product name.03700879516295:udi-di.M24857 : batch number.Expiry date: 04/01/2030.

• Brand Name: PECA® 2.0
• Common Device Name: BUNION IMPLANT Ø4 LG54/LG42
• 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: 24663283
• Report Number: 3010673777-2026-00011
• Device Sequence Number: 9289527
• Product Code: HWC
• UDI-Device Identifier: 03700879516356
• UDI-Public: 03700879516356
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143229
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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 Model Number: PS060054
• Device Lot Number: M24865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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