MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5/0.6 2MM LEFORT PLATE; CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE, NON-CUSTOMIZED

Catalog Number	01-6482
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 1.5/0.6 2mm lefort plate cat# 01-6482, lot#584040.G2: brazil.It is unknown whether the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2023 - 00437.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 11 months post implantation due to fractured plates.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 11 months post implantation due to clicking of the jaw and fractured plates.Attempts have been made and no further information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h10 visual examination of the provided picture identified two fractured lefort plates.The photo shows all of the explanted devices, and two of the plates are clearly fractured.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided, however, they were determined to be pre-operative.Therefore, the images do not capture the alleged event and radiologist review would not enhance the investigation.A definitive root cause cannot be determined.The reported event is confirmed, based on the provided photo.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 1.5/0.6 2MM LEFORT PLATE
• Common Device Name: CRANIOFACIAL FIXATION PLATE, NON-BIOABSORBABLE, NON-CUSTOMIZED
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18227597
• Report Number: 0001032347-2023-00436
• Device Sequence Number: 6221744
• Product Code: JEY
• UDI-Device Identifier: 00841036011680
• UDI-Public: (01)00841036011680(10)584040
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 01-6482
• Device Lot Number: 584040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 03/29/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/01/2023; 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Unknown