MAUDE Adverse Event Report: Medartis Inc. Incore Lapidus; Bone Screw

Catalog Number	ICLAP3550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that initial surgery with incore lapidus system was performed on (b)(6) 2024.After 7 months from the initial, the surgeon found that one of the screw was fractured.Then revision surgery was performed on (b)(6) 2025 and all implants that were implanted at initial were removed.
Additional Manufacturer Narrative
The breakage of the screw was confirmed via provision of a photo an x-ray.The product was not returned for investigation.Production records were reviewed and no anomolies were revealed.There was no evidence of design or manufacturing issues.The root cause in undertermined.

• Brand Name: Incore Lapidus
• Common Device Name: Bone Screw
• Manufacturer (Section D): Medartis Inc.; 1195 polk drive; warsaw IN 46582
• Manufacturer (Section G): Medartis Inc.; 1195 polk drive; warsaw IN 46582
• Manufacturer Contact: elise fox ; 1195 polk drive; warsaw, IN 46582 ; +1(574)376-2404
• MDR Report Key: 50059130
• Report Number: 3009540749-2026-00007
• Device Sequence Number: 15790147
• Product Code: HWC
• UDI-Device Identifier: 00817701021063
• UDI-Public: 00817701021063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ICLAP3550
• Device Lot Number: 163772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown