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

Model Number MC-SPK10

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

During the investigation of the reported complaint, the sales representative stated that when the surgeon removed the implant to evaluate and address the fluid buildup, blood was observed below the flap and above the dura.The surgeon determined that the blood/fluid buildup resulted from a hematoma, and did not detect any infection.The patient was not negatively impacted due to the reported issue.A replacement implant, which was the same in design as the original implant and provided by medcad, was implanted the same day the original implant was explanted, (b)(6) 2024.

Event Description

Patient experienced fluid build up beneath the implant.As a result, the implant had to be removed.

• 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.; unit 3; plano TX 75074
• Manufacturer Contact: madeline bowie ; 501 s second ave; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 18788111
• MDR Text Key: 336327662
• Report Number: 3009196021-2024-00003
• Device Sequence Number: 1
• Product Code: GXN
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MC-SPK10
• Device Catalogue Number: MC-SPK10
• Device Lot Number: 249279LEA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 68 KG