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

Catalog Number	CRS-075-120-01
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	04/20/2025
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
Initial surgery was performed on (b)(6) 2025 for posterior and anterior ring fixation using curvafix in s1 and anterior column (parasymphaseal); high-energy fracture.12 days post-op, the patient reported a "pop" an acute increase in pain.Follow-up found that curvafix implant (anterior column) backed out, resulting in loss of reduction.Revision surgery was discussed, which the patient declined.At this time, the patient is requesting no additional surgical intervention.
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
This is a follow-up report to document why the 30-day submission timeline was not met.During a review of complaint records on june 24, 2025, interview notes were discovered from an interview conducted with the surgeon on (b)(6) 2025 where information was provided which changed the reportability assessment from not reportable to a 30-day mdr report.The curvafix personnel responsible for complaint handling left the organization on may 13, 2025 and the notes from this event were not discovered until june 24, 2025 due to the lapse in personnel and communications, after the initial 30-day reportability window.Initial surgery was performed on (b)(6) 2025 for posterior and anterior ring fixation using curvafix in s1 and anterior column (parasymphaseal) high-energy fracture.12 days post-op, the patient reported a "pop" an acute increase in pain.Follow-up found that curvafix implant (anterior column) backed out, resulting in loss of reduction.Revision surgery was discussed, which the patient declined.At this time, the patient is requesting no additional surgical intervention.

• 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 (Section G): 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: 22571272
• Report Number: 3016537375-2025-00006
• Device Sequence Number: 3915857
• Product Code: HWC
• UDI-Device Identifier: 10855068008669
• UDI-Public: (01)10855068008669(17)290828(10)2024-02891
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222505
• 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,Followup
• Report Date (Section B): 07/23/2025

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-075-120-01
• Device Lot Number: 2024-02891
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 81 YR
• Patient Sex: Female