MAUDE Adverse Event Report: MEDCAD ACCUPLAN; INTERMEDIATE SPLINT

Catalog Number MC-K001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Physical Asymmetry (4573); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  Injury  

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 patient's maxilla advanced further than expected when the patient's teeth were seated in the intermediate dental splint.

Manufacturer Narrative

On (b)(6) 2021 medcad was notified that the use of the intermediate splint resulted in more advancement of the patient's maxilla than expected.The splint device in question was used for treatment and not for diagnosis.According to the surgical plan, this was a double jaw surgery performed maxilla-first.Through follow-up communication with the initial reporter on january 26, 2021, it was found that the surgeon modified the planned mandible surgery to adjust for the observed discrepancy in the maxillary advancement.As a result, the patient's final occlusion was reportedly not affected.The final splint, also provided by medcad, was reportedly used as expected.There was reportedly no harm to the patient as a result of this event.The initial reporter was unable to provide the weight of the patient at the time of the event.A post-operative ct scan was provided to medcad for analysis on january 27, 2021.The post-operative scan showed a discrepancy between the centric relation (cr) position of the patient's mandible compared the original cr position derived from the imaging data used to design the patient-specific intermediate splint.It was observed that the patient's cr position in the original pre-operative ct scan was set back when compared to cr position of the mandible in the post-operative scan.Becuase the design of the intermediate splint is based on the patient's pre-operative anatomy, the positioning of the patient's mandible, which was set back from the natural cr position, resulted in the splint providing more advancement than anticipated.Records contained within the device history record showed that the surgeon was provided images and measurements depicting the pre-operative occlusion and cr position of the mandible, sourced from the imaging data provided to medcad.The splint design, which was based on these anatomic relationships, was approved by the surgeon on october 28, 2020, prior to the production of the device in question.Production records indicated that the splint device was produced in accordance with established specifications.No nonconformance was identified during production.Investigation did not identify any problems related to the splint device.Investigation determined that the unintended error in the pre-operative imaging provided to medcad contributed to the observed malfunction of the splint device.

• Brand Name: ACCUPLAN
• Type of Device: INTERMEDIATE SPLINT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• MDR Report Key: 11274398
• MDR Text Key: 233463300
• Report Number: 3009196021-2021-00001
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC-K001
• Device Lot Number: 205108 FLO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR