MAUDE Adverse Event Report: BIOMET 3I; DENTAL INSTRUMENT

Device Problem Mechanical Problem (1384)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).A1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.D1: brand name unknown / not provided.D4: additional device information unknown / not provided.D10.Concomitant medical products xifnt413, osseotite tapered certain implant 4 x 13mm lot 2022091181.E1: reporter email address unknown / not provided.G4: premarket identification unknown / not provided.H4: 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.H3 other text : product not returned.

Event Description

It was reported that the driver was not correctly engaged and stripped out the implant connection during the procedure at tooth location #43.Another implant was placed.

• 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 ; 5619713230
• MDR Report Key: 17832214
• MDR Text Key: 324437687
• Report Number: 0001038806-2023-01873
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: PO
• Exemption Number: 5645646
• 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: 09/27/2023

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic