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

Catalog Number ACSS-001

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

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 03/10/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.On (b)(6) 2019, medcad contacted the initial reporter via email requesting additional information about the events described, including a request for the patient's weight.The initial reporter communicated via phone that the device was implanted on (b)(6) 2018 and explanted on (b)(6) 2019.The operating surgeon communicated via email that the patient had a history of prior infection, and that the implant was removed following erosion that the patient experienced away from any prominence in the cranioplasty plate.The surgeon communicated that he does not believe that the implant is the cause for the conditions experienced by the patient.Review of production records showed that the device was manufactured in conformance with internal requirements.No nonconformance was identified during production of this implant.Investigation did not identify any device-related problems.After requests from medcad on march 11, 2019 and (b)(6) 2019, the initial reporter was unable to provide the patient's weight.

Event Description

On march 11, 2019, a distributor sales representative notified medcad that the accushape peek patient-specific cranial implant was removed from the patient on (b)(6) 2019, after the patient experienced an infection.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. 2nd ave.; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s. 2nd ave.; suite a1000; dallas TX 75226
• Manufacturer Contact: estelle anuwe ; 501 s. 2nd ave.; suite a1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 8497156
• MDR Text Key: 141382607
• Report Number: 3009196021-2019-00004
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACSS-001
• Device Lot Number: 182952 WAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR