MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN TEMPOROMANDIBULAR JOINT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Concomitant medical products ¿ unknown screws, part# unknown, lot# unknown.The user facility is foreign; therefore a facility medwatch report will not be available.Report source - (b)(6).

Event Description

It was reported that a revision would occur due to an unknown reason.Attempts have been made to gather more information but none has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Upon further investigation, it was discovered that the device was not a zimmer biomet product and therefore zimmer biomet does not have reporting responsibility for this device.

Event Description

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

• Brand Name: UNKNOWN TEMPOROMANDIBULAR JOINT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9330747
• MDR Text Key: 166642099
• Report Number: 0001032347-2019-00490
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN TMJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention