MAUDE Adverse Event Report: BIOMET MICROFIXATION CARNEY PREBENT T1 RCN PLATE AOC; PLATE, BONE

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Perforation (2001); Skin Tears (2516)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the patient has a left tmj implant that is coming through his skin.A revision procedure is being planned.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical products: item# 24-6561, lot# 676760b, tmj system left fossa component, medium.Occupation ¿ patient's spouse.The device will not 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: 0001032347-2022-00342.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D6: explant date; unknown date in january 2023.This report is being submitted to update additional information in sections b3, b4, b5, b7, d6, e1, e2, e3, g3, g6, h2, h3, h6, and h10.
Event or Problem Description
It has been further reported that the patient underwent a revision due to the implant protruding through the skin as well as being infected.The reporter stated that the patient had passed away, but that the passing was not jaw-related.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event is confirmed, based on provided photos.

• Brand Name: CARNEY PREBENT T1 RCN PLATE AOC
• Common Device Name: PLATE, BONE
• 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: 15751841
• Report Number: 0001032347-2022-00343
• Device Sequence Number: 2868663
• Product Code: JEY
• UDI-Device Identifier: 00841036225438
• UDI-Public: (01)00841036225438(10)731440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/28/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PP-0357
• Device Lot Number: 731440
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 01/12/2023; 12/08/2023; Not provided
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/19/2023; 12/22/2023; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Male