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

Catalog Number ACSL-003

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

Patient Problem Wound Dehiscence (1154)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.On june 19, 2019, medcad received a phone call from a distributor sales representative requesting an accushape peek patient-specific implant for a patient for whom medcad had previously supplied a peek patient-specific implant.On june 25, 2019, medcad requested additional information regarding the event, via email, including the patient's weight.Communication with the initial reporter via telephone on june 28, 2019, determined that the device was explanted on (b)(6) 2018.According to communication with the initial reporter, the device was explanted after the patient experienced dehiscence at the incision site.The complainant also stated that there was "evidence of pneumocephalus underneath the bone flap." the complainant was unable to obtain the patient's weight.Review of production records determined that no nonconformities were generated during the production of the implant.Investigation was unable to determine a clear cause for the reported event.On (b)(6) 2019, medcad provided a new accushape peek patient-specific implant for the patient.

Event Description

On june 19, 2019, medcad received a phone call from a distributor sales representative requesting an accushape peek patient-specific implant for a patient for whom medcad had previously provided a peek patient-specific implant.Upon follow-up, it was reported by the distributor sales representative that the device had been explanted, after the patient experienced dehiscence at the incision site.

• 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: 8807651
• MDR Text Key: 151605583
• Report Number: 3009196021-2019-00007
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACSL-003
• Device Lot Number: 171999 YOU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2017
• 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: 59 YR