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

Catalog Number IUNIHG

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Age was not provided.Patient weight was not provided.Ethnicity no provided.Device lot # was not provided/unknown.Product has not been returned.Event date unknown.

Event Description

It was reported that abutment screw loosened.Dentist was able to retrieve the screw with no damage to the implant.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimmerbiomet complaint number: (b)(4).The certain gold-tite hexed screw iunihg was not returned.Therefore, a visual and physical/functional inspection of the product could not be performed.No photographs or radiographs of the screws were available for assessment.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: review of biomet 3i restorative ifu (p-iis086gr rev.E 11/2015) and biomet 3i restorative manual (instrm rev b 10/15) identified information regarding screw fracture and loosening under section title warnings and precautions.As per the applicable ifu, improper technique can lead to implant restoration fracture and screw loosening.Surgical manual highlights the torque recommendation under torque matrix ¿ internal connection, page iii.Also, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.Complainant reported that the screw loosened in the patient¿s mouth.The reported event could not be verified, as the product was not returned for inspection and no photographs or radiographs were available for assessment.A root cause for this complaint could not be 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
• MDR Report Key: 8121564
• MDR Text Key: 129068515
• Report Number: 0001038806-2018-00987
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 04/03/2019
• Patient Sequence Number: 1