MAUDE Adverse Event Report: MEDCAD ACCUPLAN; FINAL SPLINT

Catalog Number MC-K002

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

An investigation into the event is ongoing.A follow-up report will be filed upon completion of the investigation.

Event Description

On (b)(6) 2019, medcad was informed that an accuplan dental splint did not provide the expected advancement of the patient's maxilla.The device was expected to provide advancement of approximately 6 to 9mm, however, no advancement was observed.No injury or delay in surgery was reported.

Manufacturer Narrative

The device was used for treatment and not for diagnosis.In the initial report to medcad on (b)(6) 2019, the complainant was unable to provide detailed information regarding the alleged device malfunction.Complainant was contacted on (b)(6) 2020 for additional information about the alleged device malfunction and the weight of the patient at the time of the event.Medcad did not receive a response to this inquiry.Complainant was contacted again on (b)(6) 2020 to follow up on the information requested; however, no response was received.A review of the device history record found that the device in question was produced in accordance with all production requirements.No nonconformance was identified throughout production of the device.Investigation did not identify any device problem.Investigation was unable to determine the weight of the patient at the time of the event.

• Brand Name: ACCUPLAN
• Type of Device: FINAL SPLINT
• Manufacturer (Section D): MEDCAD; 501 s. 2nd ave.; suite a1000; dallas TX 75226
• MDR Report Key: 9578655
• MDR Text Key: 198751195
• Report Number: 3009196021-2020-00003
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC-K002
• Device Lot Number: 194018 WAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR