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	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation into the reported event is ongoing.A follow-up report will be filed upon completion of the investigation.
Event or Problem Description
The cranial implant was explanted after the patient presented with an infection.
Additional Manufacturer Narrative
On september 22, 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 september 30, 2020 the initial reporter was contacted via email for additional information about the reported adverse event.The initial reporter was contacted again on october 7, 2020.No response was received to these written requests.Attempted communication with the initial reporter was unable to determine the source or cause of the reported infection.The weight of the patient at the time of the event could not be determined through communication with the initial reporter.Investigation into the device history record was performed.According to production records, the device was produced in conformance with production requirements.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: 10726983
• Report Number: 3009196021-2020-00012
• Device Sequence Number: 19661257
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)204843OSB
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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): 11/05/2020

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: 204843OSB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/05/2020
• 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: 30 YR