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
An investigation into the reported 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 implant was explanted after the patient presented with an infection.
Additional Manufacturer Narrative
On november 16, 2020 medcad was notified by telephone that the accushape peek patient-specific cranial implant was explanted after the patient presented with an infection.The device was used for treatment and not for diagnosis.On november 18, 2020 the initial reporter was contacted via email for additional information about the reported adverse event.The information requested included additional clarification as to the nature of the reported infection, including whether the source of the infection had been identified.Also requested were the date the device in question was explanted and the weight of the patient at the time of the event.A follow up was made again on november 24, 2020 in an attempt to collect this information.Distribution records indicated that a replacement patient-specific cranial implant was provided for the patient by medcad on (b)(6) 2020.On december 9, 2020 contact with the initial reporter was made by telephone.According to the initial reporter, "everything went well" with the revision surgery using the replacement peek cranial implant.The initial reporter also stated that he would attempt to obtain the requested information from surgeon dr.(b)(6).On january 4, 2021 the initial reporter informed medcad by telephone that he was unable to obtain the requested information from dr.(b)(6).Communication with the initial reporter was unable to determine the nature of the reported infection.The date of explant and the weight of the patient at the time of the event could not be determined.Investigation into the device history record was performed.According to production records, the device was produced in conformance with all production requirements.No nonconformance was identified during production.Investigation did not identify any device problems.The cause of the reported infection could not be established.

• Brand Name: ACCUSHAPE
• Common Device Name: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• MDR Report Key: 10980069
• Report Number: 3009196021-2020-00014
• Device Sequence Number: 14261702
• Product Code: GXN
• UDI-Device Identifier: 00810007630120
• UDI-Public: (01)00810007630120(10)204847MUR
• 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: 2020
• 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): 01/18/2021

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: 204847MUR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR