MAUDE Adverse Event Report: BIOMET 3I; DENTAL ABUTMENT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

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

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that implant in site 21 was stable but the internal screw on abutment failed.Implant was removed.Site was restored and no further information was provided.

Event Description

Customer called back and stated that the screw loosened inside of the crown but would not disengage from the abutment.The implant was solid, but since they were unable to remove the screw, they removed the implant with forceps.

Manufacturer Narrative

The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.

Manufacturer Narrative

The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H6: entered evaluation codes.H10: added manufacturer narrative.

Event Description

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

Manufacturer Narrative

An unk abutment was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.((b)(6)) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and excessive damage due to the removal process.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Pre-existing conditions noted on the per are smoker/tobacco use and diabetes.The reported devices were located on tooth #21 and was used for approximately 8 months.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2019120424).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, 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.Dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review was performed for the reported lot number (2019120424) for similar event and no other complaint was identified.No complaint history review could be performed without relevant lot and item information.Based on the available information, device malfunction 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: 12980433
• MDR Text Key: 282096515
• Report Number: 0001038806-2021-02340
• 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,Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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: 06/02/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 82 KG