MAUDE Adverse Event Report: MEDCAD ACCUPLAN; FINAL SPLINT

Catalog Number MC-K002

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Physical Asymmetry (4573)

Event Date 12/08/2020

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 patient presented post-operatively with a posterior open bite.This was not the not the intended surgical result of the plan and the patient will require a revision surgery to correct the surgical outcome.

Manufacturer Narrative

On (b)(6) 2021 medcad was informed by complainant, that the patient post-operatively presented a posterior open bite.Medcad was informed that the patient would require a revision surgery to correct the surgical outcome.On (b)(6) 2021 the complainant was contacted with a follow-up, via email by medcad, requesting more information regarding the complaint such as the patient's weight at the time of surgery and details surrounding the issue.This request was met with no response and the complainant was contacted again on (b)(6) 2021, requesting the above-mentioned information.Additional follow-up requests were made on (b)(6) 2021, via email and telephone, but were yet again met with no response.On (b)(6) 2021, the complainant contacted medcad and suggested a follow-up directly with the surgeon who performed the surgery.A written request was sent directly to the surgeon via email on (b)(6) 2021.This was also met with no response.No non-conformances were observed when reviewing the device history record for this case.Medcad received approval for the patient-specific design on (b)(6) 2020.The inspection records indicated that the device was manufactured according to medcad's production requirements.The device in question was concluded to have an accepting device disposition.The conclusion of the investigation found no attributable root causes for the unintended results and no device problem identified.Medcad could not confirm whether the patient had underwent additional surgery to correct the posterior open bite.

• Brand Name: ACCUPLAN
• Type of Device: FINAL SPLINT
• Manufacturer (Section D): MEDCAD; 501 south second ave; suite a1000; dallas TX 75226
• MDR Report Key: 11648702
• MDR Text Key: 247044828
• Report Number: 3009196021-2021-00003
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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: 205233 TAN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR