FDA Adverse Event Malfunction Summary report: N

IMPL TWIST MP-1 3.75 MM 1 0 MM

MDR report key: 10174384 · Received June 19, 2020

Report

Report Number: 0002023141-2020-00917
Event Type: Malfunction
Date Received: June 19, 2020
Date of Event: May 8, 2020
Report Date: August 4, 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 WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR AND DEBRIS ABOUT THE IMPLANT THREADS FROM USE. THE MOUNT SCREW DRIVE FEATURE IS MINIMALLY WORN. FUNCTIONAL TESTING NOTES THE MOUNT SCREW TOOK AN EXCESSIVE AMOUNT OF EFFORT TO BACK OUT OF THE DRIVE FEATURE. THE REPORTED COMPLAINT WAS THEREFORE CONFIRMED. 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). AGE: PATIENT AGE NOT PROVIDED/UNKNOWN. WEIGHT: PATIENT WEIGHT NOT PROVIDED/UNKNOWN. STREET ADDRESS AND ZIPCODE UNKNOWN. ADDITIONAL 510K NUMBER: K943604.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE MOUNT COULD NOT DISENGAGE FROM THE BUNDLED IMPLANT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
640813	IMPL TWIST MP-1 3.75 MM 1 0 MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		2019040084

Patients

Seq	Age	Sex	Outcome	Treatment
1