MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM; DENTAL MOUNT

Catalog Number	NT3211
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was impossible to separate the mount from the implant #34 and was removed.Procedure completed.
Event or Problem Description
Purple external connection implant does not have mount, doctor has sent it with the implant, so a mmc15 has been added as item.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem , g3: date received by manufacturer, g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h10: additional narrative.Purple external connection implant does not have mount, doctor has sent it with the implant, so a mmc15 has been added as item.After additional information was received on mar 15, 2024, it was determined that this event no longer meets the criteria of a malfunction that if it were to recur would cause or contributed to a death and / or serious injury.As a result, the prior submission for mfr-0001038806-2024-00411 submitted on 3/8/2024 is no longer considered a reportable event by the manufacturer and no further report will be submitted for this event.

• Brand Name: OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL MOUNT
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18866205
• Report Number: 0001038806-2024-00411
• Device Sequence Number: 8239529
• Product Code: DZE
• UDI-Device Identifier: 00844868011972
• UDI-Public: (01)00844868011972(17)280316(10)2023030391
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: NT3211
• Device Lot Number: 2023030391
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic