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

Model Number MC-SPK20

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

It was reported by the sales representative that an explant surgery was performed on (b)(6) 2022 due to the surgical site infection.The plan of action was to provide antibiotics until the infection was cleared and then perform surgery again to replace explanted device with a new implant.

Event Description

It was reported that the patient has a known post-operative infection of the surgical site.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s second ave; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s second ave; suite a1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 s second ave; dallas, TX 75226 ; 2144538864
• MDR Report Key: 15886659
• MDR Text Key: 304530813
• Report Number: 3009196021-2022-00010
• 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: Other
• Type of Report: Initial
• Report Date: 11/18/2022

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
• Device Operator: Health Professional
• Device Model Number: MC-SPK20
• Device Catalogue Number: MC-SPK20
• Device Lot Number: 227377 HER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54.3 YR
• Patient Sex: Male
• Patient Weight: 108 KG