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 Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the cranial implant was explanted after the patient presented with 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
• MDR Report Key: 10426388
• Report Number: 3009196021-2020-00008
• Device Sequence Number: 2990726
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)204458SCH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 204458SCH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR