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

Catalog Number ACS_XL_D

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.Evaluation of the device could not be completed as no device was returned to medcad.Device is not expected to be returned.It was reported by a company representative that prior to the implantation surgery, on the date of surgery, the patient displayed an open sore over a previous titanium mesh implant.The site was treated with an antiseptic and the device was implanted.A review of the device history record (dhr) was performed for the specific lot number.A review of the device's labeling and production records was performed as well.Evaluation is still in progress.A follow-up report will be submitted as appropriate once investigation is complete or if information is obtained that was not available for the initial report.

Event Description

On (b)(6) 2017, medcad received notification from a distributor that an accushape peek patient-specific implant, as well as supporting unknown plates and screws, were removed from a patient.The distributor reported that the device was implanted on (b)(6) 2017 and that the device was removed from the patient on (b)(6) 2017, after the patient returned with an open wound over the implant site.It was reported by a company representative that prior to the implantation surgery, on the date of surgery, the patient displayed an open sore over a previous titanium mesh implant.The site was treated with an antiseptic and the device was implanted.

Manufacturer Narrative

Review of the device's production records revealed that no nonconformities were generated during the production of this device that would contribute to the condition described in this event.Review of the device's labeling revealed that instructions for use were provided that included contraindications, warnings, and sterilization instructions to be used to ensure that the implant is sterile.Requests for additional information, including a request for the patient's weight, were attempted on 11/09/2017, 11/20/2017, and 02/20/2018.Medcad has not received further information from the initial reporter.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. 2nd ave.; suite a-1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s. 2nd ave.; suite a-1000; dallas TX 75226
• Manufacturer Contact: estelle anuwe ; 501 s. 2nd ave.; suite a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 7068007
• MDR Text Key: 93247123
• Report Number: 3009196021-2017-00008
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K110684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: ACS_XL_D
• Device Lot Number: 171742 SAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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): Other
• Patient Age: 9 YR