MAUDE Adverse Event Report: BIOMET 3I 3I T3 PARALLEL WALLED IMPLANT 4/3 X 10MM; DENTAL IMPLANT

Catalog Number	BOPS4310
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the cover screw that came with the bops4310 turned on its own and would not close.The doctor asked for it to be investigated.It was completed with a different implant.Tooth site #20.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) bops4310, (3i t3 parallel walled implant 4/3 x 10mm) for evaluation.Visual evaluation / functional test was performed, the returned cover screw engaged and disengaged with the bundled implant as intended.Measurements match drawing.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2021071191.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2021071191 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : device malfunction.The customer submitted an image for the reported event.Image shows an implant and cover screw inside a sterile bag.A definitive root cause could not be determined since the device malfunction did not occur, and the reported event has been unconfirmed following physical evaluation.Therefore, based on the available information, a device malfunction did not occur.The no malfunction was identified as the cover screw closed on returned bundled implant.The reported event was not confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: 3I T3 PARALLEL WALLED IMPLANT 4/3 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: 20112569
• Report Number: 0001038806-2024-01969
• Device Sequence Number: 12600048
• Product Code: DZE
• UDI-Device Identifier: 00844868028390
• UDI-Public: (01)00844868028390(17)260806(10)2021071191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122300
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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 Expiration Date: 08/05/2026
• Device Catalogue Number: BOPS4310
• Device Lot Number: 2021071191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/30/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic