MAUDE Adverse Event Report: MEDCAD ACCUPLAN SYSTEM; IMAGE PROCESSING SYSTEM

Model Number	MC-K000
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right inferior alveolar nerve was damaged during the sagittal split osteotomy.
Additional Manufacturer Narrative
An investigation into the reported adverse event is ongoing.A follow-up report will be filed upon the completion of this investigation.
Additional Manufacturer Narrative
On june 8, 2022, it was reported by distributor sales representative that the patient's right inferior alveolar nerve was damaged during the bsso procedure.The surgeon questioned whether the nerve measurements provided by medcad in the surgical plan were accurate.The complainant forwarded medcad an image of where the sagittal split osteotomy was made.It was determined that the surgeon deviated from the location of the osteotomy as shown in the approved surgical plan by making the osteotomy behind the second molar, as opposed to between the first and second molars.On june 9, 2022, medcad met with the surgeon to review the surgical plan and the ct scan data provided for the surgical planning.The surgeon indicated his preference for making sagittal split osteotomies behind the second molar as the reason for deviating from the surgical plan communicated to medcad.While reviewing the ct scan, the surgeon observed approximately 3 scan slices in which a bifurcated inferior alveolar nerve was visible.The bifurcated portion of the nerve was not detected by medcad personnel when the ct scan was initially segmented becuase it was difficult to visualize in the scan.A post-operative ct scan was not provided for analysis; however, it is likely that both the bifurcated nerve that was not identified in the scan, as well as the deviation from the approved surgical plan contributed to the reported injury.The surgical team was reportedly able to resolve the issue during surgery.Through followup communication with the complainant on june 23, and again on june 30, 2022, medcad requested additional information about the patient's condition.No response to these requests was received.It could not be determined whether the patient experienced any additional health impacts secondary to this event.The weight of the patient at the time of the event was not provided.
Event or Problem Description
It was reported that the patient's right inferior alveolar nerve was damaged during the sagittal split osteotomy.

• Brand Name: ACCUPLAN SYSTEM
• Common Device Name: IMAGE PROCESSING SYSTEM
• 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 ; 2144538864
• MDR Report Key: 14941154
• Report Number: 3009196021-2022-00006
• Device Sequence Number: 4763344
• Product Code: DZJ
• UDI-Device Identifier: 00810007630298
• UDI-Public: (01)00810007630298(10)226881CRI
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: MC-K000
• Device Catalogue Number: MC-K000
• Device Lot Number: 226881 CRI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Female