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

Catalog Number ACSX-004

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

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Device used for treatment and not diagnosis.Evaluation of the device could not be completed, as no device was returned.Exact date of implant and exact date of explant are unknown.A device history record (dhr) review was performed for the specific lot number.Review of the dhr, device labeling and production records showed that there were no issues during the manufacture of the device that would contribute to the condition described in this complaint.Correspondence with the complainant indicated that prior to implantation, the device was not handled appropriately in accordance with the instructions for use that were provided.Specifically, fixation materials were applied to the device prior to sterilization, which conflicts with the instructions for use that state "any loose materials that are not part of the implant should be removed before processing." a corrective action was initiated.If more information is obtained that was not available for the initial report, a follow-up report will be filed, as appropriate.

Event Description

Medcad received notification that an accushape peek patient-specific implant was removed from a patient after the patient experienced an infection.

• 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.; ste. a-1000; dallas TX 75226
• Manufacturer Contact: estelle anuwe ; 501 s. 2nd ave.; ste. a-1000; dallas, TX 75226 ; 2144538864
• MDR Report Key: 6998059
• MDR Text Key: 90935540
• Report Number: 3009196021-2017-00006
• 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: Physician
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACSX-004
• Device Lot Number: 161491 GIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• 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: 35 YR