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

Model Number	MC-SPK40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant reported an explant due to a post-operative infection.Review of device production records did not identify any device problems or establish a clear cause for the reported infection.Attempts to acquire additional information such as patient weight and further details regarding the surgical outcome were made; however, the complainant was not able to provide the patient weight or comment on the cause of the infection based on the information he had received from the healthcare professional.
Event or Problem Description
It was reported that the patient experienced a post-operative infection and the implant was explanted as a result.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIENT SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s second ave; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s second ave; suite a1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 s second ave; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 17135733
• Report Number: 3009196021-2023-00003
• Device Sequence Number: 3930418
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)238077RHO
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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
• Device Model Number: MC-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 238077 RHO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male