FDA Adverse Event Malfunction Summary report: N

ABUT GOLD FRICTION-FIT 3. 5MM IMP

MDR report key: 7390037 · Received April 2, 2018

Report

Report Number: 0001038806-2018-00345
Event Type: Malfunction
Date Received: April 2, 2018
Report Date: August 13, 2018
Manufacturer: ZIMMER DENTAL
Product Code: DZE
PMA / PMN Number: PK011028
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 0

NO PRODUCT WAS RETURNED FOR INSPECTION. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: ¿INSTRUCTIONS FOR USE FOR ZIMMER DENTAL IMPLANT SYSTEMS¿ 4894I REV 3-07/09 INFORMATION IDENTIFIED: SEATING OF PROSTHETIC COMPONENTS INTERNAL HEX OR OCTAGON COMPONENTS - TO PROPERLY SEAT THESE PROSTHETIC COMPONENTS, PLACE THE ABUTMENT RETAINING SCREW THROUGH THE ABUTMENT AND PLACE THE ASSEMBLY INTO THE INTERNAL BEVEL AT THE CORONAL PORTION OF THE IMPLANT. ROTATE IT UNTIL THE ABUTMENT DROPS INTO PLACE. THE MALE HEX OR OCTAGON SHOULD SEAT FULLY IN THE FEMALE HEX OR OCTAGON OF THE IMPLANT ONCE THE TORQUE WRENCH HAS BEEN USED TO TIGHTEN THE ABUTMENT TO 30NCM. COMPLAINT INDICATES CONTINUOUS ABUTMENT LOOSENING. THE ALLEGED EVENT WAS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. A ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 1

PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED ((B)(4)). AGE AND DATE OF BIRTH UNKNOWN/NOT PROVIDED. WEIGHT UNKNOWN/NOT PROVIDED. LOT NUMBER UNKNOWN/NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER K013227/K953101.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE HLA3G ABUTMENT LOOSENED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
233013	ABUT GOLD FRICTION-FIT 3. 5MM IMP	ABUTMENT	DZE	ZIMMER DENTAL

Patients

Seq	Age	Sex	Outcome	Treatment
1