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

Catalog Number IUNIHG

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2015

Event Type  Injury  

Event Description

The head of the abutment screw broke off inside the implant placed in tooth site #19.The dentist was unable to retrieve the screw causing the implant having to be removed by trephining.The patient was seen one week post op and was healing well.The patient sustained no permanent or on-going impairment or medical condition.

Manufacturer Narrative

The fractured portion of the screw was not returned.Upon visual inspection, bone and blood residues were seen in the external surface of the implant, indicative of patient contact.The inspection confirmed the fractured condition.The screw was broken off inside the implant, the depth of the threads have been blocked.The screw lot number was not provided therefore a review of the device history record could not be performed, however the device history record review of the implant was performed.No nonconformance or rework activities were found for this implant lot that would cause or contribute to the condition reported.A definitive root cause has not been determined.

• Brand Name: CERTAIN® GOLD-TITE® HEXED SCREW
• 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: 5028874
• MDR Text Key: 23986850
• Report Number: 0001038806-2015-00770
• 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: Other Health Care Professional
• Type of Report: Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: No
• 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