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)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation into the reported adverse event is ongoing.A follow-up report will be filed upon completion of the investigation.
Event or Problem Description
It was reported that the cranial implants were explanted after the patient experienced an infection.
Additional Manufacturer Narrative
On january 7, 2022, medcad contacted the initial reporter via email to request additional information about the reported event.The information requested included the nature of the infection experienced by the patient, any potential causes or contributing factors, and the weight of the patient at the time of the event.On january 18, 2022, medcad received a response; however, the complainant was not able to provided the requested information.On february 14, 2022, medcad completed a review of the device history record for the suspect devices (see also report number 3009196021-2022-00001).Investigation into the device history record found that the devices in question were produced in accordance with all required production standards.No nonconformance was identified throughout the production of the devices in question.No device problem was identified through investigation.The investigation did not establish a cause for the reported infection.
Event or Problem Description
It was reported that the cranial implants were explanted after the patient experienced 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 75226
• Manufacturer (Section G): MEDCAD; 501 south second ave.; suite a1000; dallas TX 75226
• Manufacturer Contact: james allo ; 501 south second ave.; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 13358322
• Report Number: 3009196021-2022-00002
• Device Sequence Number: 1648031
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)216153MOO
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 216153MOO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female