MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED CERTAIN IMPLANT 5 X 10MM; DENTAL IMPLANT

Catalog Number	IFNT510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.Product has been received by zimvie and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during implant placement, the implant at tooth location #19 was stripped.A new implant was placed during the same procedure.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the initial report, mfr report number 0001038806-2024-02316 that was submitted on october 11, 2024 is a duplicate of mfr report number 0001038806-2024-02271.Therefore, this supplemental mw is being submitted as a retraction due to duplication of mfr report number 0001038806-2024-02271.All details associated with this event have been processed and completed under 0001038806-2024-02271.Therefore, no additional reports will be submitted under mfr report number 0001038806-2024-02316.The following sections are being reported: b4: date of this report was updated.B5: event description was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H10: narrative/data was updated.
Event or Problem Description
This report is being submitted to retract the initial report, mfr report number 0001038806-2024-02316 that was submitted on october 11, 2024 as this event had already been submitted and is a duplicate of mfr report number 0001038806-2024-02271 that was submitted on october 4, 2024.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 5 X 10MM
• Common Device Name: DENTAL IMPLANT
• 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: 20431925
• Report Number: 0001038806-2024-02316
• Device Sequence Number: 20739821
• Product Code: DZE
• UDI-Device Identifier: 00844868005056
• UDI-Public: (01)00844868005056(17)270114(10)2021120897
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: Health Professional
• Device Catalogue Number: IFNT510
• Device Lot Number: 2021120897
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2024
• 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: 10/11/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic