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 Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

Three attempts to obtain information such as the weight of the patient, nature of the infection, and date of the explant from the sales representative; however, the details were not provided.It was only reported that the implant was explanted prior to (b)(6) 2022 and no exact date was provided.

Event Description

It was reported that the accushape peek cranial implant would be explanted.The details and nature of the event are unknown.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 south second ave; suite a1000; dallas, TX 75226 ; 2142648864
• MDR Report Key: 15589364
• MDR Text Key: 301592629
• Report Number: 3009196021-2022-00009
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)227008NIC
• Combination Product (y/n): Y
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 227008NIC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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: 36.8 YR
• Patient Sex: Male