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

Model Number MC-SPK30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Investigation into the reported event is ongoing.A follow-up report will be filed upon completion of the investigation.

Event Description

The cranial implant was explanted after the patient presented with an infection.

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
• Type of Device: PEEK PATIENT-SPECIFIC CRANIAL IMPLANT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• MDR Report Key: 10726983
• MDR Text Key: 212744897
• Report Number: 3009196021-2020-00012
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00810007630113
• UDI-Public: (01)00810007630113(10)204843OSB
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: 204843OSB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR