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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Perforation (2001); Skin Tears (2516)

Event Type  Injury  

Event 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.

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.

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 Description

No further event information is available at the time of this report.

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 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 Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: CARNEY PREBENT T1 RCN PLATE AOC
• Type of Device: 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
• MDR Text Key: 303230330
• Report Number: 0001032347-2022-00343
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036225438
• UDI-Public: (01)00841036225438(10)731440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Male