MAUDE Adverse Event Report: BIOMET MICROFIXATION CARECCI PM-TMJ & MODEL; CUSTOM

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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.

Event Description

It was reported a patient underwent initial surgery tmj procedure.Subsequently, the patient was revised due to bone erosion.The patient has a fracture in the mandible and status quo is that they are planning to do a reconstruction with stryker.The lower mandible plate will be cut to gain access to the area of concern.

Event Description

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

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 records identified no deviations or anomalies during manufacturing related to the reported event.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

It has been further reported that the patient is being planned for a revision using tmjpm products from zimmer biomet.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, g3, g6, h2, and h10.

Manufacturer Narrative

This report is being submitted to correct information in section h2 as no fda request was made.This should have been noted as additional information in previous submission.

Event Description

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

• Brand Name: CARECCI PM-TMJ & MODEL
• Type of Device: CUSTOM
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12739163
• MDR Text Key: 279773487
• Report Number: 0001032347-2021-00479
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036206727
• UDI-Public: (01)00841036206727(17)210201(10)664320
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2022

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 Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1315
• Device Lot Number: 664320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 03/21/2022; 03/21/2022; 04/05/2022
• Supplement Dates FDA Received: 03/24/2022; 04/08/2022; 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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): Hospitalization; Required Intervention