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

Catalog Number	CRS-075-130-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/26/2025
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 treated for an anterior ring parasymphaseal injury was treated with two curvafix implants in the s1 and the ac on (b)(6) 2025.An interview with the implant surgeon was held on (b)(6) 2025 when the surgeon commented that the patient required a blood transfusion owing to blood loss during device implantation surgery on (b)(6) 2025.

• Brand Name: CURVAFIX IM IMPLANT
• Common Device Name: PELVIC FIXATION DEVICE
• Manufacturer (Section D): CURVAFIX; 1406140th pl ne, suite 107; bellevue WA 98007
• Manufacturer Contact: nathan clark ; 1406 140th pl ne suite 107; bellevue, WA 98007
• MDR Report Key: 22160991
• Report Number: 3016537375-2025-00004
• Device Sequence Number: 20709375
• Product Code: HWC
• UDI-Device Identifier: 10855068008676
• UDI-Public: (01)10855068008676(17)290423(10)92408-5
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 05/23/2025

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-075-130-01
• Device Lot Number: 92408-5
• 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: 04/25/2025
• Initial Report FDA Received Date: 06/06/2025
• 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: 77 YR
• Patient Sex: Female