MAUDE Adverse Event Report: MEDCAD ACCUPLATE; CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE

Model Number	MC-K035
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon found a roughly 5 mm gap between graft on the patient left and native mandible when fixating a custom bone plate to the mandible.Surgical representative reported that there appeared to be no issue with the plate-graft / plate-mandible interface.
Additional Manufacturer Narrative
More than three (3) attempts were made via email, phone call, and text to obtain additional information; however, the complainant was not able to provide information such as patient weight, details on the device malfunction, complications during the surgery, or any information regarding the status of the patient post-operatively.Rep did confirm the surgery was completed successfully.The surgical representative has been told to contact medcad if any more information is received from the surgeon or other medical professionals regarding the status of the patient.Medcad will submit an additional information follow-up report within 30 calendar days of receiving information from the surgical rep / surgeon.

• Brand Name: ACCUPLATE
• Common Device Name: CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDCAD; 501 s second ave; dallas TX 75226
• Manufacturer (Section G): MEDCAD; 501 s second ave; dallas TX 75226
• Manufacturer Contact: madeline bowie ; 501 s second ave; dallas, TX 75226 ; 2144538864
• MDR Report Key: 16766052
• Report Number: 3009196021-2023-00002
• Device Sequence Number: 14265674
• Product Code: JEY
• UDI-Device Identifier: 00810007630410
• UDI-Public: (01)00810007630410(10)237892MAB
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: MC-K035
• Device Catalogue Number: MC-K035
• Device Lot Number: 237892 MAB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male