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

Model Number	CRS-075-130-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthralgia (2355); Ambulation or Postural Difficulties (2544)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
18 months after implantation, a curvafix im implant was identified as having been broken after patient imaging.The patient had reported pain and developed a limp.As of the date of this report, the subject implant remains implanted in the patient.The surgeon has indicated a revision surgery is planned but not yet scheduled.
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 or does not apply, the section/field of the form is left blank.

• 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; 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: 19943110
• Report Number: 3016537375-2024-00001
• Device Sequence Number: 14671558
• Product Code: HWC
• UDI-Device Identifier: 10855068008676
• UDI-Public: (01)10855068008676(17)271121(10)87290-3
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K222505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/08/2024

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-075-130-01
• Device Catalogue Number: CRS-075-130-01
• Device Lot Number: 87290-3
• 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: 07/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2022
• 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: TOTAL HIP REPLACEMENT WITH NEW ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White