MAUDE Adverse Event Report: BIOMET 3I; DENTAL ABUTMENT

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Brand name unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported that crown / abutment fractured.Unable to retrieve screw.Implant removed.

Manufacturer Narrative

One osseotite certain 2 implant 5 x 10mm (xifoss510) was returned for investigation and one unknown biomet abutment was not returned for investigation.Implant was fractured at the collar and abutment fracture could not be determined.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing condition noted on the per was low bone density ¿ type iii.The reported device had been placed on tooth #16 (fdi) for approximately 9 years.X-ray or picture image was not provided.Appropriate documentation was reviewed.Dhr review for the lot (2012020173) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2012020173) for similar events and no other complaint was identified.Dhr, sterilization, and complaint history review could not be performed, as the subject lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.Feb post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction (implant) did occur, and the reported event was confirmed.Device malfunction (abutment) could not be verified, and the reported event was non-verifiable.

Event Description

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

• Type of Device: DENTAL 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: 16067821
• MDR Text Key: 306331677
• Report Number: 0001038806-2022-01996
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female