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

Catalog Number ACSS-001

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.On (b)(6) 2018, a distributor sales representative informed medcad that the accushape patient-specific implant did not provide adequate defect coverage.According to the complainant, there was more retraction in the temporalis region of the defect than the surgeon had requested.Review of production records for the case show that upon review of the implant design, the surgeon requested additional retraction from the patient's native bone.Review of the design file shows that the implant was redesigned and manufactured with more retraction than the surgeon requested.On (b)(6)2018, the complainant informed medcad that the implant was not used to complete the surgery on (b)(6) 2018, due to unintended fit.According to the complainant, surgery was successfully completed using titanium mesh instead of the accushape cranial implant.If additional information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2018, a distributor sales representative notified medcad that the accushape peek patient-specific cranial implant did not provide adequate defect coverage.As a result, the implant was not used to complete the surgery.

• 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: 8737659
• MDR Text Key: 149363901
• Report Number: 3009196021-2019-00005
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ACSS-001
• Device Lot Number: 182312 SIN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• 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 Age: 28 YR