FDA Adverse Event Malfunction Summary report: N

ABUTMENT, PATIENT SPECIFIC, TITANIUM

MDR report key: 6668688 · Received June 26, 2017

Report

Report Number: 0001038806-2017-00347
Event Type: Malfunction
Date Received: June 26, 2017
Date of Event: May 31, 2017
Report Date: October 5, 2017
Manufacturer: BIOMET 3I
Product Code: NHA
PMA / PMN Number: PK071493
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS REQUESTED AND NOT RETURNED (PHOTOS (3) WERE RECEIVED SHOWING THE LABEL, ABUTMENT, DENTAL CROWN AND SCREW). PMA 510(K): K143505. NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative · 1

ONE PSATH4M ABUTMENT WITH SCREW WAS RETURNED FOR INSPECTION. A VISUAL INSPECTION REVEALED THAT THE SCREW WAS FRACTURED. THE CONDITION OF THE SCREW PRIOR TO THE FRACTURE IS UNKNOWN. THEREFORE, THE LOOSENING EVENT CANNOT BE VERIFIED. 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 OTHER COMPLAINTS INITIATED AGAINST THIS LOT. A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED. COMPLAINT IS THEREFORE NON-VERIFIABLE. UDI# (B)(4).

Additional Manufacturer Narrative · 1

ABUTMENT, ABUTMENT SCREW, AND CROWN RECEIVED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT AN ABUTMENT AND SCREW WERE PLACED ON (B)(6) 2016. ON (B)(6)2017 THE ABUTMENT AND SCREW WERE DETERMINED TO BE LOOSE AND DETACHED FROM IMPLANT. THE PATIENT RETURNED FOR THE PLACEMENT OF AN ADDITIONAL ABUTMENT AND CROWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
448287	ABUTMENT, PATIENT SPECIFIC, TITANIUM	IMPLANT ABUTMENT AND SCREW	NHA	BIOMET 3I		63321268

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR