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

Catalog Number MC-SPK40

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

Patient Problem Injury (2348)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.A replacement accushape peek patient-specific cranial implant was provided by medcad on (b)(6) 2019.On august 26, 2019, medcad was informed by the initial reporter that the original patient-specific cranial implant had been explanted and that the replacement was implanted without incident during the same procedure.The initial reporter was unable to provide the patient's weight at the time of the event.On september 9, 2019, medcad contacted the initial reporter via email to obtain additional information about the events described, including a description of the patient health condition that led to the explant of the device.The initial reporter was unable to provide medcad with additional details as to the reason for the explant.Upon follow up via email on (b)(6) 2019, the initial reporter informed medcad, "i am not sure if it was infection or lack of tissue coverage / healing that led to the re operation.I know the scalp was very thin and provided a complex closure over the defect." review of production records found that the device was manufactured in accordance with medcad's production requirements.No nonconformance was detected throughout the production of the device.Investigation was unable to establish a cause for the reported event.

Event Description

On (b)(6) 2019, medcad received a service request from a distributor sales representative requesting an accushape patient specific cranial implant (psci) for a patient for whom medcad had previously provided an accushape psci.The sales representative stated that the skin over the implant was "bad" and needed to be repaired, after use of a tissue expander.Upon follow up with the sales representative on (b)(6) 2019, medcad was informed that the device in question was explanted on (b)(6) 2019.The sales representative was unable to confirm to medcad the cause for explant.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC CRANIAL 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: 9121017
• MDR Text Key: 162342272
• Report Number: 3009196021-2019-00008
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MC-SPK40
• Device Lot Number: 193301 VAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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: 58 YR