FDA Adverse Event Malfunction Summary report: N

IMPL TWIST MP-1 5.0 MM 10 MM

MDR report key: 9739705 · Received February 21, 2020

Report

Report Number: 0002023141-2020-00360
Event Type: Malfunction
Date Received: February 21, 2020
Date of Event: January 21, 2020
Report Date: April 15, 2020
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 IMPLANT WAS RETURNED WITH ITS RESPECTIVE MOUNT FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE ALONG THE THREADS/HA COATING AND DRIED BLOOD AROUND THE DEVICE. IT WAS DETERMINED THE DEVICE FAILED FUNCTIONAL TESTING AS THE MOUNT COULD NOT BE REMOVED FROM THE IMPLANT. 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. H3: CHANGED "NO" TO "YES".

Description of Event or Problem · 0

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

Additional Manufacturer Narrative · 1

ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBERS: K962106.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE MOUNT WAS NOT ABLE TO BE DISENGAGED FROM THE IMPLANT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT. TOOTH LOCATION 31.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
204858	IMPL TWIST MP-1 5.0 MM 10 MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		2018090238

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR