MAUDE Adverse Event Report: BIOMET 3I UNKNOWN 3I SCREW; ABUTMENT SCREW

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that the screw had fractured inside of the implant resulting in the implant being removed.The patient will have to return for a new implant.Tooth #19.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

One 3i t3® tapered implant 6/5 x 13mm, bopt6513 was returned for investigation.Visual inspection identified unknown b3i fractured screw within the drive feature of the implant.Per: pre-existing conditions noted on the complaint: diabetes.Bone density type unknown.The reported device was located on tooth #19 (universal).Picture/x-rays: no pictures or x-ray images were provided.Review of appropriate documentation: instructions for use: biomet 3i dental implants (p-iis086gi rev.H ¿ 07/2021)/biomet 3i restorative products ifu (p-iis086gr) rev f ¿ october 2019.Information identified: contraindications, warnings, precautions, breakage, general considerations and adverse effects.Per ifu: fracture may occur when abutment is loaded beyond its functional capability.Dhr review: dhr review could not be performed for the reported unknown biomet screw since the lot number was not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review: a complaint history review for the unknown biomet screw could not be performed as the lot/item numbers were unknown.Post market trend review: april post market trending was reviewed and there were no negative trends or corrective actions for the reported event (fracture screw) and device (bopt6513 & unknown biomet screw).Malf/event: based on the available information, device malfunction did occur and the reported event was confirmed following inspection and evaluation.Sections updated: b4: date of this report g3: date investigation results were received g6: type of report and follow up number h2: follow up type h3: device evaluated h6: adverse event problem codes h10: manufacturer's narrative.

• Brand Name: UNKNOWN 3I 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13090357
• MDR Text Key: 283162425
• Report Number: 0001038806-2021-02422
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2022
• 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
• Treatment: IMPLANT - BOPT6513
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male