FDA Adverse Event Malfunction Summary report: N

IMPL TWIST MP-1 3.75 MM 1 0 MM

MDR report key: 9513139 · Received December 23, 2019

Report

Report Number: 0002023141-2019-01365
Event Type: Malfunction
Date Received: December 23, 2019
Date of Event: November 15, 2019
Report Date: February 27, 2020
Manufacturer: ZIMMER DENTAL
Product Code: DZE
PMA / PMN Number: K013494
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

ONE IMPLANT WITH MOUNT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED MINIMAL WEAR MARKINGS DUE TO USAGE. NO VISIBLE DAMAGE OR DEFORMATION WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT WITH AN IN-HOUSE STOCK DEVICE AND THE MOUNT COULD NOT BE DISENGAGED/RELEASE FROM PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. THE ALLEGED DEVICE MALFUNCTION WAS CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

Description of Event or Problem · 0

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative · 1

ZIMMER BIOMET COMPLAINT (B)(4). PATIENT AGE AND WEIGHT NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBER: K943604. DEVICE NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING PLACEMENT, THE IMPLANT AND MOUNT WOULD NOT DISENGAGE. THE IMPLANT AND MOUNT COME BUNDLED AND PRE-ASSEMBLED. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1307324	IMPL TWIST MP-1 3.75 MM 1 0 MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		63845338

Patients

Seq	Age	Sex	Outcome	Treatment
1