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

Catalog Number ACS-LG-E

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

Patient Problems Hemorrhage, Extradural (1890); Seizures (2063); Injury (2348)

Event Date 07/05/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020 it was reported that the accushape peek patient-specific cranial implant was explanted to stabilize the patient after the patient had reportedly experienced seizures.The device was used for treatment and not for diagnosis.On (b)(6) 2020, the initial reporter was contacted via email for additional information, including the patient's weight at the time of the event.According to the initial reporter, the seizures were caused by extradural bleeding.Communication with the initial reporter was unable to determine the cause of the extradural bleeding, however, the initial reporter indicated that the bleeding occurred as a result of surgery.The weight of the patient at the time of the event could not be obtained by the initial reporter.Investigation was conducted into the device history record.No nonconformance was identified during production.Investigation did not identify any device problems.

Event Description

It was reported that the cranial implant was explanted after the patient experienced seizures.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• Manufacturer (Section G): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• Manufacturer Contact: james allo ; 501 south second ave; suite a1000; dallas, tx ; 4538864
• MDR Report Key: 10368656
• MDR Text Key: 201844004
• Report Number: 3009196021-2020-00007
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACS-LG-E
• Device Lot Number: 204536 SCO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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 Outcome(s): Other
• Patient Age: 19 YR