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

Model Number	7.5 MM X 180 MM
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025 it was reported that a patient implanted on (b)(6) 2024 experienced l5 nerve root issues.The cause was determined by the physician to be implant malposition.The malpositioned implant was removed on (b)(6) 2024 and a new implant was placed.They physician reported symptoms resolved after the initial implant was removed and a new implant was correctly placed.
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.The suspect device was not returned for evaulation.A lot history record review was conducted for the subject device.There was no evidence to suggest the device did not meet specifications before distribution.

• Brand Name: CURVAFIX IM IMPLANT
• Common Device Name: PELVIC FIXATION DEVICE
• Manufacturer (Section D): CURVAFIX; 1406 140th pl ne; suite 107; bellevue WA 98007
• Manufacturer (Section G): CURVAFIX; 1406 140th pl ne; suite 107; bellevue WA 98007
• Manufacturer Contact: sabrina gunderson ; 1406 140th pl ne; suite 107; bellevue, WA 98007 ; 4252768800
• MDR Report Key: 21284438
• Report Number: 3016537375-2025-00001
• Device Sequence Number: 15399161
• Product Code: HWC
• UDI-Device Identifier: 10855068008720
• UDI-Public: (01)10855068008720(17)290401(10)92409-8
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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 Model Number: 7.5 MM X 180 MM
• Device Catalogue Number: CRS-075-180-01
• Device Lot Number: 92409-8
• 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: 01/02/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STRAIGHT SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 68 KG