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

Model Number	ZB-SPK30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Tissue Breakdown (2681)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the production records and complainant correspondence did not identify a device problem associated with the reported infection.The infection occurred as a result of tissue breakdown from post-operative radiation.
Event or Problem Description
Patient experienced infection at the original incision site due to tissue breakdown from post-operative radiation.As a result, the implant was explanted.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIET-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. second ave; suite a-1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 s secod ave; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 19244180
• Report Number: 3009196021-2024-00006
• Device Sequence Number: 7107836
• Product Code: GXN
• UDI-Device Identifier: 00810007630625
• UDI-Public: (01)00810007630625(10)238646STR
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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: ZB-SPK30
• Device Catalogue Number: ZB-SPK30
• Device Lot Number: 238464 STR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 98 KG