MAUDE Adverse Event Report: BIOMET 3I; DENTAL INSTRUMENT

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age at time of the event unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Brand name unknown / provided.Type of the device unknown / not provided.Additional device information unknown / not provided.Email address unknown / not provided.Premarket identification unknown / not provided.Device manufacturer date unknown / not provided.Since the lot number and device will not be returned , identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.Product not returned.

Event Description

The doctor reports that the implant came out of the driver and fell to the ground.The affected dental position is unknown.The procedure was completed satisfactorily.

• Type of Device: DENTAL INSTRUMENT
• 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: 15303481
• MDR Text Key: 304354994
• Report Number: 0001038806-2022-01326
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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