MAUDE Adverse Event Report: MEDCAD ACCUSHAPE; CRANIPLASTY PLATE

Model Number MC-SPK30

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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 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.

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
• Type of Device: CRANIPLASTY PLATE
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• MDR Report Key: 9904291
• MDR Text Key: 191106568
• Report Number: 3009196021-2020-00005
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)193764BAK
• Combination Product (y/n): N
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MC-SPK30
• Device Catalogue Number: MC-SPK30
• Device Lot Number: 193764BAK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR