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

Model Number	CRS-075-120-01
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A curvafix device was malpositioned during initial implantation.A secondary surgical procedure was performed to remove the malpositioned implant.
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.Lot number of the subject device is unknown but based on surgical case usage determined to be either lot number 89090-3, dom 2023-05-05 or lot number 2024-02891, dom 2024-08-28.

• 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 98007
• Manufacturer Contact: sabrina gunderson ; 1406 140th pl ne; suite 107; bellevue 98007
• MDR Report Key: 21944539
• Report Number: 3016537375-2025-00003
• Device Sequence Number: 8553837
• Product Code: HWC
• UDI-Device Identifier: 10855068008669
• UDI-Public: (01)10855068008669(17)YYMMDD(10)XXXXXXX
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K222505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/01/2025

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: CRS-075-120-01
• Device Catalogue Number: 7.5 MM X 120 MM
• Device Lot Number: UNKNOWN
• 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: 04/02/2025
• Initial Report FDA Received Date: 05/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TWO ADDITIONAL CURVAFIX IM IMPLANTS.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic
• Patient Race: White