MAUDE Adverse Event Report: MEDCAD ACCUSHAPE; CRANIPLASTY PLATE

Model Number	MC-SPK30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by distributor sales representative that the patient had an infection at the implant site and that the accushape patient-specific cranial implant was planned to be explanted.Investigation into the reported adverse event is underway.A follow-up report will be filed pending completion of the investigation.
Event or Problem Description
It was reported that the patient presented with an infection at the implant site and that the cranial implant was planned to be explanted.
Additional Manufacturer Narrative
The device in question was used for treatment and not for diagnosis.Investigation was conducted into the reported event.On march 10, 2020, the initial reporter was contacted via email to obtain additional information about the reported event, including whether the device in question had been explanted.No response was received.Initial reporter was contacted again on march 30, 2020 in an attempt to obtain this information, however, no response was received.On april 28, 2020 initial reporter was contacted via telephone.Initial reporter could not confirm whether the device in question had been explanted and was unable to provide the patient's weight at the time of the event.Investigation of the device history record was conducted.Production records indicated that the device was manufactured in accordance with medcad's production requirements.No nonconformance was observed throughout the production of the device.Investigation was unable to establish a cause for the reported event.

• Brand Name: ACCUSHAPE
• Common Device Name: CRANIPLASTY PLATE
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• MDR Report Key: 9904291
• Report Number: 3009196021-2020-00005
• Device Sequence Number: 2814484
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)193764BAK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: 193764BAK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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: 67 YR