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

Model Number	MC-SPK30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	09/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an infection was detected and the left-sided peek cranial implant had to be removed.
Additional Manufacturer Narrative
It was reported that the left-sided accushape peek patient-specific implant was explanted.The complainant requested another cranial implant of the same design and stated the patient experienced a wound infection.No additional surgical outcomes were reported at the time of the investigation.

• 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.; a1000; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 south second ave/; suite a1000; dallas, TX 75226 ; 2142648864
• MDR Report Key: 15567095
• Report Number: 3009196021-2022-00008
• Device Sequence Number: 2822034
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)227075MAG
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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-SPK30
• Device Catalogue Number: MC-SPK30
• Device Lot Number: 227075MAG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74.9 YR
• Patient Sex: Male
• Patient Weight: 88 KG