MAUDE Adverse Event Report: MEDCAD ACCUPLAN; INTERMEDIATE SPLINT

Catalog Number MC-K001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

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

It was reported that the use of the intermediate splint did not result in the expected advancement of the mandible.The surgeon was expecting 9 mm of advancement; however, when the splint was removed, "the mandible immediately fell back approximately 1/2 cm." this discrepancy was corrected during surgery and there was no impact to the patient as a result of the reported malfunction.According to the surgeon, this was a "minor discrepancy" and that the patient "will have an excellent result.".

Manufacturer Narrative

Upon receipt of the complaint report, medcad contacted the surgeon via email on july 08, 2020 to obtain additional information about the reported malfunction.The surgeon indicated that to correct the discrepancy in the patient's lower jaw position, surgery was performed on the patient's upper jaw as planned, then, "with the maxilla and final splint used we removed all hardware from the mandible and re-plated it in its correct position." the surgeon stated, "again, the patient will have an excellent result and she is doing fine this morning at her postoperative check." the surgeon requested to meet with medcad to further discuss potential causes for the observed discrepancy.On august 07, 2020, medcad contacted the surgeon's office via telephone to arrange a meeting with the surgeon.On august 12, 2020, medcad followed up with the surgeon's office via email to request the meeting.Medcad's repeated requests to meet with the surgeon to further discuss the case were not met.Communication with the surgeon could not determine the cause of the reported malfunction or the weight of the patient at the time of the event.The device history record was reviewed.Production records did not indicate any nonconformance.In-process inspection records indicated that the device in question was produced in accordance with all production requirements.Investigation into the reported event was unable to identify a device problem.The cause of the reported malfunction could not be determined.A follow-up report will be filed as appropriate if additional information becomes available.

• Brand Name: ACCUPLAN
• Type of Device: INTERMEDIATE SPLINT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas, tx
• MDR Report Key: 10368594
• MDR Text Key: 201772101
• Report Number: 3009196021-2020-00006
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC-K001
• Device Lot Number: 204813 BOA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR