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

Model Number MC-SPK40

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The complainant reported an explant due to a post-operative infection.The implant was implanted on (b)(6) 2023.The complainant reported that he became aware of the infection on (b)(6) 2023 but did not know when the implant was explanted but knows it was shortly after the infection was found.The complainant notified medcad on 01/30/2024 and requested a new implant to be manufactured for the patient.Attempts to acquire additional information such as patient weight, date of explant, and state of the patient's condition were made by medcad; however, the complainant was unable to provide the additional information but was able to share that the patient was in good condition and would be receiving a new implant soon.

Event Description

Patient developed an infection after implantation of the peek cranial implant.Implant was subsequently removed.Date of explant is unknown.

• 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: 18759978
• MDR Text Key: 336055247
• Report Number: 3009196021-2024-00002
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 237939 SMI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Male