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

Catalog Number ACSM-002

Device Problems Patient-Device Incompatibility (2682); Device Handling Problem (3265)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not for diagnosis.Evaluation of the device could not be completed as the device was discarded after explant.The exact date of implant and exact date of explant are unknown.A review of the device history record (dhr) for this specific lot number was performed.A review of the labeling and production records for this lot number was also performed.Evaluation for this event is still in progress.A follow-up report will be filed as appropriate once evaluation is complete or if additional information is obtained that was not available for the initial report.

Event Description

On march 3, 2017, medcad received notification from a sales representative that an accushape peek patient-specific implant was removed from a patient.It was reported by the sales representative that the device was implanted in (b)(6) 2016, and that the device was removed in 2017 after the patient experienced an infection.Exact date of implant and exact date of explant are unknown.

Manufacturer Narrative

Review of the device's production records revealed that the device was manufactured in compliance with medcad's manufacturing procedures.Medcad was notified on 03/23/2017 by the complainant via phone call that the device had been handled in a way that was not in accordance with the specification provided in the instructions for use.Specifically, fixation materials were added to the implant prior to sterilization.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 patient's weight, were attempted on 10/19/2017 via email and 10/24/2017 via phone.Medcad has not received further information from the complainant.

• Brand Name: ACCUSHAPE
• Type of Device: PEEK PATIENT-SPECIFIC IMPLANT
• Manufacturer (Section D): MEDCAD; 501 s. 2nd ave.; ste. 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: 7065427
• MDR Text Key: 93168245
• Report Number: 3009196021-2017-00007
• 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,health profession
• 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: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACSM-002
• Device Lot Number: 161517 MAX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2016
• 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: 46 YR