1.1 MM MDI SURGICAL DRILL (STERILE)

MDR report key: 2758463 · Received September 21, 2012

Report

Report Number: 3005174370-2012-00021
Event Type: Injury
Date Received: September 21, 2012
Date of Event: July 18, 2012
Report Date: August 21, 2012
Manufacturer: 3M ESPE DENTAL PRODUCTS
Product Code: DZA
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

METHOD, RESULTS AND CONCLUSIONS: THE FRAGMENTS OF THE DRILL INVOLVED IN THIS CASE WERE NOT RETURNED TO 3M ESE FOR EVAL.

Description of Event or Problem · 1

ON (B)(6) 2012, IT WAS REPORTED TO 3M ESPE THAT A DRILL BROKE DURING AN IMPLANTATION PROCEDURE FOR A MDI (B)(4) IMPLANT ON (B)(6) 2012. HOWEVER, THE FRAGMENT OF THE DRILL WAS LEFT IN THE BONE AND THE IMPLANT WAS INSERTED ON THE FRAGMENT. THREE MONTHS LATER, THE IMPLANT BECAME LOOSE AND WAS REMOVED. SUBSEQUENTLY, THE FRAGMENT OF THE DRILL WAS REMOVED USING A LINDEMANN BUR. THE SURGERY WAS PERFORMED WITHOUT COMPLICATION. ACCORDING TO THE DENTIST THE PT IS FINE. IT IS NOT KNOWN IF A NEW IMPLANT WAS SET.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	1.1 MM MDI SURGICAL DRILL (STERILE)	DENTAL DRILL	DZA	3M ESPE DENTAL PRODUCTS	S1011	N282925

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR		Required Intervention