MAUDE Adverse Event Report: BIOMET 3I GOLD-TITE® SQUARE UNISCREW; DENTAL SCREW

Catalog Number UNISG

Device Problem Fracture (1260)

Patient Problems Inflammation (1932); Osteolysis (2377)

Event Date 10/19/2021

Event Type  Injury  

Event Description

Doctor reported that 2 screws placed at tooth 36 and 37 fractured inside the implants and implants were removed.A portion of the screws remains inside the implants.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Additional device information unknown / not provided.Device manufacturer date unknown / not provided.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Two full osseotite® tapered implant 4 x 11.5mm, fnt411 was returned for investigation.Visual inspection via naked eye and camera magnification was completed.Fractured screw fragments were identified in the implants.Implant damage identified from the removal process which may also have caused bone loss at the sites.Device history record (dhr) review could not be performed as the lot number associated with the unisg is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review for the unisg x 2 could not be performed as the lot/item numbers were unknown.Based on the available information, device malfunction did occur and the reported event was confirmed.

Event Description

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

• Brand Name: GOLD-TITE® SQUARE UNISCREW
• Type of Device: DENTAL 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13649648
• MDR Text Key: 286425799
• Report Number: 0001038806-2022-00292
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072642
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNISG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 90 KG