MAUDE Adverse Event Report: MEDCAD ACCUSHAPE; PEEK PATIENT-SPECIFIC CRANIAL IMPLANT

Model Number MC-SPK20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 02/19/2024

Event Type  Injury  

Event Description

Patient experienced infection post implantation.Implant was explanted.

Manufacturer Narrative

The sales representative was requested information such as the date of explant, additional information regarding the patient infection, other surgical outcomes or effects on the patient, and the patient's weight; however, they were not able to provide any of the requested information as of (b)(6) 2024.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. second ave; suite a-1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 3401 technology dr.; plano TX 75074
• Manufacturer Contact: madeline bowie ; 501 s second ave; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 18997355
• MDR Text Key: 338881279
• Report Number: 3009196021-2024-00005
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630160
• UDI-Public: (01)00810007630160(10)249226MOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MC-SPK20
• Device Catalogue Number: MC-SPK20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male