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

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment and not diagnosis.Evaluation of the device could not be completed, as no devices were returned.Device is not expected to be returned for evaluation.Exact date of implant and exact date of explant are unknown.According to the complainant, the patient and family of the patient have a history of reaction to implants.No testing was completed to confirm source of reaction.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.If 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 patient experienced a reaction to the implant and that the implant was removed.

• 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: 6979887
• MDR Text Key: 90330212
• Report Number: 3009196021-2017-00005
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: ACSS-001
• Device Lot Number: 161539 REY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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: 44 YR