MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® TITANIUM ABUTMENT 4.1MM

Model Number ILDAT4

Device Problems Positioning Failure (1158); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient id not provided.Patient age not provided.Patient weight not provided.

Event Description

It was reported that there was damage to the upper hex of implant during seating of abutment.Could not seat abutment properly, had to order angled abutment and will have to re-do crown.Tooth #19.

Event Description

Customer provided an update to confirm that the doctor was able to successfully place a new abutment on top of the existing implant without any issues.

Manufacturer Narrative

Supplemental report provided as the customer provided an update to the complaint description previously provided under mfr #0001038806 - 2022 - 01314.Sections updated: b4: date of this report.B5: update to complaint description.G3: date additional information was received.G6: type of report and follow up number.H2: follow up type.H10: manufacturer's narrative.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were updated: 3331, 4110, 4111, 4114.H6: investigation findings code was updated: 213.H6: investigation conclusion code was updated: 4315.H10: narrative/data was updated.One certain® bellatek® titanium abutment 4.1mm, ildat4 was not returned for investigation.Based on the evaluation, the device malfunction could not be verified.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.The abutment was milled in good faith that the design provided was from an accurate replication of the patient¿s mouth, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Dhr review was completed for the subject lot number (8732527-1).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Monthly post market trending review identified no adverse trends or corrective actions for the reported events or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and conforming when they left zimmer biomet.A lot number specific complaint history review is not conducted for psp complaints.Patient specific products have a unique one-time use lot number.Therefore, a lot number specific history search for this complaint is not performed.Based on the investigation and risk review, the most likely cause for the reported event per rm-00057-haz (rev 18) is incorrect design for patient restorative space/excessive torque due to customer error.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

Event Description

No additional event information was received at the time of this report.

• Brand Name: CERTAIN® BELLATEK® TITANIUM ABUTMENT 4.1MM
• Type of Device: ABUTMENT
• 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: 15292545
• MDR Text Key: 304975252
• Report Number: 0001038806-2022-01314
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868031406
• UDI-Public: (01)00844868031406(10)8732527-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052648
• 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: 02/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ILDAT4
• Device Catalogue Number: ILDAT4
• Device Lot Number: 8732527-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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: UNKNOWN BIOMET IMPLANT
• Patient Sex: Female