MAUDE Adverse Event Report: CURVAFIX, INC. CURVAFIX IM IMPLANT; PELVIC FIXATION DEVICE

Catalog Number	CRS-075-170-01
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by fda, curvafix, or its employees that the report constitutes an admission that the device, curvafix, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available, not disclosed, or does not apply, the section/field of the form is left blank.
Event or Problem Description
A patient had an implant removed on (b)(6) 2025 due to painful hardware.The retrograde anterior ring implant broke at the proximal end during removal.The remaining distal end of the implant was retained in the patient.The proximal head's prominence caused the pain and its removal eliminated the pain.The surgeon determined there was no clinical benefit to removing the distal portion of the implant.

• Brand Name: CURVAFIX IM IMPLANT
• Common Device Name: PELVIC FIXATION DEVICE
• Manufacturer (Section D): CURVAFIX, INC.; 1406 140th pl ne, suite 107; bellevue WA 98007
• Manufacturer Contact: nathan clark ; 1406 140th pl ne; suite 107; bellevue, WA 98007
• MDR Report Key: 22332925
• Report Number: 3016537375-2025-00005
• Device Sequence Number: 18418198
• Product Code: HWC
• UDI-Device Identifier: 10855068008713
• UDI-Public: (01)10855068008713(17)281205(10)91343-8
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K222505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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 Catalogue Number: CRS-075-170-01
• Device Lot Number: 91343-8
• 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: 06/11/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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: 56 YR
• Patient Sex: Male