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

Model Number	MC-SPK40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient-specific cranial implant was explanted due to an infection.
Additional Manufacturer Narrative
Investigation into the reported adverse event is ongoing.A follow-up report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
On march 15, 2022, medcad contacted the initial reporter via email to request additional information about the reported infection.The requested information included the type of infection the patient experienced, any potential causes or contributing factors, and information about how the device was handled at the user facility.On march 16, 2022, medcad completed a review of the device history record for the device in question.This investigation found that the device in question was produced in accordance with all production requirements.No nonconformance was identified throughout the production of the device.A replacement cranial implant was provided for the patient on (b)(6) 2022.The initial reported was contacted again on april 29, 2022 as a follow up on whether the revision procedure had been completed and to again request additional information about the reported infection.No response was received from these inquiries.No device problem was identified through investigation.The investigation did not establish a cause for the reported infection.If additional information becomes available, a follow up report will be submitted.
Event or Problem Description
It was reported that the patient-specific cranial implant was explanted due to an infection.

• Brand Name: ACCUSHAPE
• Common Device Name: 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: james allo ; 501 south second ave.; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 14024999
• Report Number: 3009196021-2022-00004
• Device Sequence Number: 14963828
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)215720BRO
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 215720BRO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 41 KG