MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ BELLATEK¿ ENCODE¿ EMERGENCE HEALING ABUTMENT 5MM(D) 6MM(P) 5MM(H); DENTAL HEALING ABUTMENT

Catalog Number IEEHA565

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.D10: unknown dental implant, lot number unknown.E1: initial reporter¿s title is not provided / unknown.

Event Description

It was reported that the implant at tooth site # 19 was removed as the implant has broken abutment screw, not able to be retrieved in it.Symptoms as a result of the event: pain.

• Brand Name: CERTAIN¿ BELLATEK¿ ENCODE¿ EMERGENCE HEALING ABUTMENT 5MM(D) 6MM(P) 5MM(H)
• Type of Device: DENTAL HEALING 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18410707
• MDR Text Key: 331520563
• Report Number: 0001038806-2023-02513
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868045618
• UDI-Public: (01)00844868045618(17)280410(10)1266164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212730
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IEEHA565
• Device Lot Number: 1266164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic