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

Model Number	MC-SPK30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three attempts were made via email to obtain additional information; however, the complainant was not able to provide information such as patient weight and date of event.
Event or Problem Description
Patient presented a post-operative infection.

• 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: 16675353
• Report Number: 3009196021-2023-00001
• Device Sequence Number: 12099045
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)227228MAG
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: MC-SPK30
• Device Catalogue Number: MC-SPK30
• Device Lot Number: 227228 MAG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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: 75 YR
• Patient Sex: Male