MAUDE Adverse Event Report: VISIONARE LLC CMF VISIONARE; 1.904.006 - 4 HOLE LONG STRAIGHT MINIPLATE, T 1.0MM

Model Number	1.904.006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the health professional description: "during the year 2024, (b)(4) company started the exclusive supply of orthoses, prostheses and special fixation materials for the specialty of buco-maxilo-facial, with the supply of visionare brand fixing plates.During this period, i noticed a significant increase in patients who evolved to fracture of the plates installed in the jaw, without apparent reason.The fracture of the fixation plates can interfere with the healing of the jaw, causing bad occlusions, pseudoarthrosis, osteomyelitis, among other problems, which will often be solved with new surgical interventions." complaint occurred in brazilian market.This content was translated from portuguese to english by visionare.The original complaint reported 4 plates broken, however, data from only 3 patients were shared.This occurrence generated the need to notify adverse events to anvisa through notification no.(b)(4).This event will be accounted for and monitored through post-market surveillance activities.If additional information becomes available, the investigation will be updated as applicable.As there are occurrences with 3 different patients, the company will make 3 adverse events notifications at fda.Investigation: it was evidenced that the implant 1.904.006 were applied in the orthognathic surgical technique, which is not recommended.Visionare has a specific line of products for such application, so we recommended that for orthognathic surgery procedure, the specific implants of visionare orthognathic line be used.The rhp (historical production record) of the batch of the occurrences' object was also evaluated and no divergences were observed in the modes of failures that could lead to the reported occurrences, showing that the products met the level of safety and effectiveness established by the project.Based on the above-mentioned assessment, this complaint being categorized as unfounded.
Additional Manufacturer Narrative
We fully respect the surgeon's decision to use a product that is not ideal for the intended technique, so regarding the "plate breakage", we suggest monitoring the evolution of each patient's clinical condition and if necessary, provide for the replacement of broken plate by the plate indicated for orthognathic surgery.We remain entirely at the disposal of the authorities, if there any additional questions.

• Brand Name: CMF VISIONARE
• Common Device Name: 1.904.006 - 4 HOLE LONG STRAIGHT MINIPLATE, T 1.0MM
• Manufacturer (Section D): VISIONARE LLC; 12251 towne lake drive; fort myers FL 33913 8012
• Manufacturer (Section G): VISIONARE LLC; 12251 towne lake drive; fort myers FL 33913 8012
• Manufacturer Contact: marina adami ; 12251 towne lake drive; fort myers, FL 33913-8012 ; 2392442973
• MDR Report Key: 21037156
• Report Number: 3011196443-2024-00003
• Device Sequence Number: 20747384
• Product Code: JEY
• UDI-Device Identifier: 00810004511170
• UDI-Public: (01)00810004511170(11)230720(10)2808409
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180204
• 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
• Report Date (Section B): 12/30/2024

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
• Device Model Number: 1.904.006
• Device Catalogue Number: 1.904.006
• Device Lot Number: 2808409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male