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

Catalog Number ACSX-004

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

Patient Problem Unspecified Infection (1930)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.On (b)(6) 2018, medcad contacted the initial reporter via email to obtain additional information about the events described, including the patient's weight.The initial reporter stated via email that the infection experienced by the patient was due to a previous infection.Additional attempts were made to request more information on january 4, 2019, and again on january 10, 2019.As of the date of this report, medcad has not received a response to these requests.Review of production records found that the device was manufactured in accordance with medcad's production requirements.No nonconformities were identified during the production of the device.Investigation was unable to identify any problems with the device.

Event Description

On (b)(6) 2018, a distributor sales representative notified medcad that the accushape peek patient-specific implant was removed from the patient on (b)(6) 2018, 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: 8376662
• MDR Text Key: 137361857
• Report Number: 3009196021-2019-00003
• 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: 02/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: ACSX-004
• Device Lot Number: 183027 PHI
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2018
• 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: 15 YR