FDA Adverse Event Injury Summary report: N

IMPLANTIUM

MDR report key: 2234040 · Received August 29, 2011

Report

Report Number: 3005503242-2011-00060
Event Type: Injury
Date Received: August 29, 2011
Date of Event: July 21, 2011
Report Date: July 29, 2011
Manufacturer: DENTIUM USA
Product Code: DZE
PMA / PMN Number: K041368
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE MARKETING SAMPLE PRODUCT FROM THE SAME LOT HAS BEEN FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, THERE WAS NO DEVIATION IN THE TITANIUM MATERIAL USED TO MANUFACTURE THE COMPLAINT IMPLANT. THE OVERALL SUCCESS RATE FOR DENTAL IMPLANTS IS ABOUT 95%. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THEN THE PRODUCT SUCH AS SURGICAL MISTAKE, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR.

Description of Event or Problem · 1

THE PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE THE IMPLANT FRACTURED. BASED ON THE REPORT, THE PT HAD MODERATE ORAL HYGIENE AND GOOD BONE CONDITION. TRADITIONAL 2 STAGE SURGERY WAS DONE. A SINGLE PROSTHETIC ATTACHMENT WAS USED. FIXTURE WAS PLACED IN TOOTH LOCATION #11. ALLOGRAFT WAS USED AS A BONE GRAFT MATERIAL AT THE SITE. THE PT HAS A MEDICAL HISTORY OF BRUXISM SINCE ALMOST 20 YEARS. SHE USE TO GRIND HER TEETH AT THAT POINT. SHE WAS ADVISED TO WEAR A NIGHT GUARD HOWEVER SHE DID NOT DO SO. THE IMPLANT WAS REMOVED BECAUSE IT WAS FRACTURED. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED. THE PT OUTCOME WAS REPORTED AS RECOVERED WITH NO COMPLICATIONS. THE PT WAS SENT BACK HOME WITH A LITTLE FLIPPER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IMPLANTIUM	ENDOSSEOUS DENTAL IMPLANT	DZE	DENTIUM USA	FX3410MLC	07K1602

Patients

Seq	Age	Sex	Outcome	Treatment
1	92 YR		Required Intervention