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

Model Number MC-SPK40

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

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

On july 22, 2020, it was reported that the accushape peek patient-specific cranial implant was explanted after the patient presented with an infection.The cranial implant was used for treatment and not for diagnosis.On august 06, 2020, the initial reporter was contacted via email for additional information, including the date of the reported explant and the patient's weight at the time of the event.The initial reporter was unable to provide the exact date the device was explanted, but stated that the explant occurred approximately 1-2 months after it was implanted.According to case records, the device was implanted on (b)(6) 2020.Therefore, the explant likely occurred between approximately (b)(6) 2020 - (b)(6) 2020.The initial reporter was unaware of any testing being performed to identify the source of the infection.The initial reporter was unable to provide the patient's weight at the time of the event.Investigation into the device history record found that the device was produced in accordance with all production requirements.No nonconformance was identified during production.Investigation was unable to establish the cause of the reported infection.

Event Description

It was reported that the cranial implant was explanted after the patient presented with an infection.

• 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: 10426388
• MDR Text Key: 203864566
• Report Number: 3009196021-2020-00008
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)204458SCH
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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: 204458SCH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 18 YR