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

Model Number	MC-SPK40
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
Investigation into the event is ongoing.A follow-up report will be filed upon completion of the investigation.
Event or Problem Description
It was reported that the patient presented post-operatively with an unspecified infection and would require explantation of the cranial implant.
Event or Problem Description
It was reported that the patient presented post-operatively with an unspecified infection and would require explantation of the cranial implant.
Additional Manufacturer Narrative
On (b)(6) 2021 medcad contacted the initial reporter via email to request additional information about the reported event.The information requested included the nature of the infection the patient reportedly experienced, any potential causes, and the date of the device explant.The initial reporter was contacted by phone on (b)(6) 2021 as a follow-up to the previous email.On (b)(6) 2021, medcad made a third attempt to contact the initial reporter, again via email.No response was received to medcad's requests for additional information.On (b)(6) 2021 medcad completed a review of the device history record for the suspect device.Investigation into the device history record found no evidence of nonconformance with any established production process.No device problem was identified.The investigation did not establish a cause for the reported 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: 12674708
• Report Number: 3009196021-2021-00006
• Device Sequence Number: 11090161
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)215818ZOL
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/18/2021

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-SPK40
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 215818ZOL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: 24 YR
• Patient Sex: Male
• Patient Weight: 67 KG