MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H)

Catalog Number IEHA343

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The lab reported a screw was damaged and that another abutment was used.It was also reported that it appears the head of the screw is sheared off.

Manufacturer Narrative

Upon visual inspection, it was found that the head of the screw was completely severed and missing.The screw threads appeared in good condition.The review of the device history record did not provide any indication of a manufacturing deviation that would cause this condition.A definitive root cause has not been determined.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H)
• Type of Device: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 5825341
• MDR Text Key: 50642962
• Report Number: 0001038806-2016-00186
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/16/2021
• Device Catalogue Number: IEHA343
• Device Lot Number: 1192470
• Other Device ID Number: (01)00844868004516(17)210216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1