FDA Adverse Event Injury Summary report: N

2.4X15MM MDI MAX WITH O-BALL HEAD AND COLLAR

MDR report key: 3925502 · Received June 18, 2014

Report

Report Number: 3005174370-2014-00019
Event Type: Injury
Date Received: June 18, 2014
Date of Event: March 18, 2014
Report Date: May 19, 2014
Manufacturer: 3M ESPE DENTAL PRODUCTS
Product Code: DZE
PMA / PMN Number: K081653
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

SINCE THE DENTAL PROFESSIONAL WAS UNABLE TO PROVIDE THE TORQUE VALUE THAT THE IMPLANT WAS EXPERIENCING AT THE TIME OF FRACTURE, IT IS NOT KNOWN IF FORCES BEYOND THOSE THAT 3M ESPE RECOMMENDS WERE EXCEEDED. THE 3M ESPE INSTRUCTIONS FOR USE INDICATE THAT A FORCE OF 45NCM SHOULD NOT BE EXCEEDED DURING IMPLANT PLACEMENT. THE COMPLAINT HISTORY FOR THIS PRODUCT DOES NOT SHOW ANY PATTERN OR TREND IN THE NUMBER OF FRACTURE COMPLAINTS. THE PRODUCT HAS BEEN RETURNED TO 3M ESPE AND IS AWAITING ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE ANALYSIS HAS BEEN COMPLETED.

Description of Event or Problem · 1

ON (B)(6) 2014, 3M ESPE WAS INFORMED OF THE FRACTURE OF A DENTAL IMPLANT WHICH RESULTED IN AN ADDITIONAL SURGICAL PROCEDURE. DURING PLACEMENT OF AN 2.4X15MM MDI MAX WITH O-BALL HEAD AND COLLAR IMPLANT (MOB-15) IN THICK MANDIBULAR BONE, THE BALL HEAD OF THE IMPLANT FRACTURED AND THE DENTIST CREATED A TROUGH IN THE BONE TO REMOVE THE REMAINING PART OF THE IMPLANT. AT THE TIME OF THE FRACTURE, THE DENTIST HAD JUST SWITCHED TO USING A TORQUE WRENCH TO FINAL PLACEMENT, BUT DID NOT RECORD THE TORQUE VALUE. THE PATIENT IS REPORTED AS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356725	2.4X15MM MDI MAX WITH O-BALL HEAD AND COLLAR	IMPLANT, ENDOSSEOUS, ROOT-FORM	DZE	3M ESPE DENTAL PRODUCTS	MOB-15	M514968

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention