MAUDE Adverse Event Report: MEDCAD ACCUPLAN; INTERMEDIATE SPLINT

Catalog Number MC-K001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Physical Asymmetry (4573)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

On april 20, 2021 medcad was informed by complainant via text messages and phone call regarding an alleged malfunction relating to the intermediate splints used in case (b)(4) hod.The splint in question was placed into occlusion during surgery and was observed to promote minimal advancements on the right lefort segment and the left segment showed a 6mm advancement.These unintended advancements seemed to "mirror" what was presented in the surgical plan.The final splints that were supplied were not used in the surgery.The doctor who performed the surgery for this case, indicated that "the patient looks good" after a one-week patient follow-up, in an in-person conversation with the customer services manager on (b)(6) 2021.Attempts to collect information, such as the patient's weight at the time of surgery and whether the surgery was prolonged, were made during this conversation but was not provided.Surgeon approval for the splint design was confirmed on (b)(6) 2021.Device history record review of case (b)(4) hod identified no non-conformances related to the production of the device in question and was manufactured according to medcad's production requirements.Inspection of the device was performed on (b)(6) 2021 and passed fit inspection against patient-specific dental models.Conclusion of this investigation found no clear root-cause for this alleged malfunction.

Event Description

The maxillary and mandibular advancements that were called out in the orthognathic digital surgical plan (dsp), were not reflective of what was observed during the surgery when the intermediate splints were used.The orthognathic dsp called for 6.1mm advancement on the pt.Right lefort segment and 0.8mm advancement on the pt.Left leftort segment, but when the intermediate splints were placed into occlusion during surgery, the maxillary advancements were observed to be the opposite of the plan's intended advancements.Similarly, the mandibular advancements were observed to be the opposite as what was called out in the orthognathic dsp.

• Brand Name: ACCUPLAN
• Type of Device: INTERMEDIATE SPLINT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• Manufacturer Contact: james allo ; 501 south second ave; suite a1000; dallas, TX 75226
• MDR Report Key: 11849419
• MDR Text Key: 251449452
• Report Number: 3009196021-2021-00004
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 215631 HOD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR