FDA Adverse Event Malfunction Summary report: N

IMPL TWIST MP-1 3.75 MM 1 0 MM

MDR report key: 9157068 · Received October 4, 2019

Report

Report Number: 0002023141-2019-00846
Event Type: Malfunction
Date Received: October 4, 2019
Date of Event: September 7, 2019
Report Date: December 19, 2019
Manufacturer: ZIMMER DENTAL
Product Code: DZE
PMA / PMN Number: K013494
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

ONE IMPL TWIST MP-1 3.75 MM 1 0 MM (1989) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINIMAL SIGNS OF USE ABOUT THE IMPLANT THREADS, MOUNT, AND MOUNT SCREW. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT AND IT WAS DETERMINED THAT THE IMPLANT CANNOT BE DISENGAGED FROM THE MOUNT WHEN THE SCREW WAS ATTEMPTED TO BE BACKED OUT. 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

(B)(4). ADDITIONAL 510K NUMBER: K943604.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE MOUNT COULD NOT BE REMOVED FORM THE IMPLANT BODY. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. THE MOUNT IS BUNDLED WITH THE IMPLANT. TOOTH LOCATION 20.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
949630	IMPL TWIST MP-1 3.75 MM 1 0 MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		2018091247

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR