MAUDE Adverse Event Report: BIOMET 3I; DENTAL ABUTMENT

Device Problem Positioning Failure (1158)

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

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age and date of birth unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D1: brand name unknown / not provided.D4: lot/serial # unknown / not provided.D4: device expiration date unknown / not provided.D4: device udi number unknown / not provided.G4: pma/510(k) number unknown / not provided.H4: device manufacturer date unknown / not provided.

Event Description

It was reported that the encode emergence is more difficult to seat properly.Doctor feels there is a changed hex tolerance between the original encode and encode emergence.The emergence tolerance seems to be tighter and more difficult to seat.The doctor estimated the group has had more than 30 cases where seating is an issue since launch.Contacted customer and sales rep for additional information but neither had any specifics regarding previous occurrences besides that they were able to complete the procedures either by backing the screw slightly to get the abutment to seat properly or replacing it with the original encode.

Manufacturer Narrative

Zimvie did not receive one (1) unknown encode emergence ha for evaluation.Visual inspection could not be performed.The investigation has been performed based on all available information, complaint history review (chr), and the risk management file (rmf).Dhr review by lot number could not be performed, as the item/lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the unknown encode emergence ha dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: ¿dental : fit : does not seat¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was the improper placing of screw or the abutments internal connection (abutment-implant interface) anti-rotational feature is designed too wide or the clinician selects incorrect abutment size.Please note, a definitive root cause could not be determined because the device was not returned.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported coob was non-verifiable, since the condition of the product/packaging when received by the customer are unknown / non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

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 ; 5619713230
• MDR Report Key: 17504006
• MDR Text Key: 321134432
• Report Number: 0001038806-2023-01524
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/12/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic