MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H); LOW PROFILE ABUTMENT

Catalog Number ILPC441U

Device Problems Fracture (1260); Difficult to Remove (1528)

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

Event Date 01/04/2017

Event Type  Injury  

Event Description

The dentist reported that screw fractured screw inside the of implant three-and-a-half years after implantation.Doctor was unable to remove the fractured screw from the implant therefore implant was removed.

Manufacturer Narrative

During of the investigation, the lot number provided by the dentist did not match with ilpc441 certain® low profile one-piece abutment 4.1mm(d) x 1mm(h) in our records.Attempts were made to get information regarding the lot number, and lot #2013032112 was change to unknown.Upon visual inspection, an evidence of the fractured abutment was observed inside of the implant.The complaint was confirmed.The returned abutment also was fractured.The lot number was not provided; therefore, a device history record review could not be completed.A definitive root cause has not been determined.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)
• Type of Device: LOW PROFILE ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I DENTAL IBERICA SL; c/islas baleares, 50; pol. ind. fuente del jarro; paterna, valencia
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6348722
• MDR Text Key: 67934765
• Report Number: 0001038806-2017-00053
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK092341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ILPC441U
• Device Lot Number: 2013032112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN DENTAL IMPLANT
• Patient Outcome(s): Required Intervention