MAUDE Adverse Event Report: BIOMET MICROFIXATION TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; SCREW

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Numbness (2415)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The part number of the screw was not provided.Therefore, the 510k cannot be determined.There are two possible 510k numbers for screws intended for use with the tmj system, k910038 and k113512.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient experienced numbness in their lip.Therefore, the patient underwent a revision to remove and replace a tmj screw that was near a nerve.No additional patient consequences were reported.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.There was a revision to remove and replace the screw, therefore, the complaint is considered confirmed.Functional testing and inspections could not be performed due to the part not being returned and no photographs, x-rays, ct scans, or physician reports being provided.The dhr could not be reviewed due to the part and lot number being unknown.There are no indications of manufacturing defects.Based on the information and materials provided, the most likely underlying cause of the complaint 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.

• Brand Name: TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8658543
• MDR Text Key: 146657623
• Report Number: 0001032347-2019-00309
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN TMJ PROSTHESIS, CATALOG#: NI, LOT#: NI; UNKNOWN TMJ PROSTHESIS, CATALOG#: NI, LOT#: NI
• Patient Outcome(s): Hospitalization; Required Intervention