MAUDE Adverse Event Report: BIOMET 3I CERTAIN GOLD-TITE TM HEXED SCR; ABUTMENT SCREW

Catalog Number IUNIHG

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # - (b)(4).Remains implanted.

Event Description

The dentist reported the screw fractured inside implant and was unable to retrieve.The dentist plans to remove the implant, perform bone graft, and place a new implant.

Manufacturer Narrative

The product associated with this complaint was not received.The customer did provide a radiograph for review; however the image does not provide any conclusive information regarding the restoration.The complaint could not be verified.The device history record review for the screw lot and the implant lot was performed and did not identify any non-conformances.A definitive root cause has not been determined.

Manufacturer Narrative

One nanotite tm certain® prevail® implant 5/4 x 11.5mm was received for inspection.The internal drive feature is confirmed to contain the reported fractured screw, which was too badly damaged to be removed.A device history review was performed and no related nonconformance¿s were noted.A device history review was performed and no related nonconformance¿s were noted.Also a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Appropriate documentation was reviewed and the following information was identified: biomet 3i restorative manual instrm rev c 09/16.Information identified: the biomet 3i restorative manual was confirmed to contain instruction on screw placement as well as recommended torque values.In the case of biomet 3i titanium abutment screws, it is recommended to torque at 20ncm.Complaint indicates screw fracture, which necessitated implant removal.Alleged event was confirmed following inspection.A singular cause could not be identified.

Event Description

It was reported that the abutment was loose in patient mouth, the abutment screw (iunihg) was unevenly fractured.Customer tried to removed screw but was unsuccessful.Implant was removed site was bone grafted and new implant was placed.

• Brand Name: CERTAIN GOLD-TITE TM HEXED SCR
• Type of Device: ABUTMENT SCREW
• 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: 5719916
• MDR Text Key: 47213751
• Report Number: 0001038806-2016-00138
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2019
• Device Catalogue Number: IUNIHG
• Device Lot Number: 1178000
• Other Device ID Number: (01)00844868008538(17)191009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• 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
• Patient Outcome(s): Required Intervention