MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	NT411
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported hex transformation.When the doctor performed a reverse rotation, the hex became deformed, so he removed it.Initially, the implant was inserted within the prescribed torque value, but when it reached its limit, the doctor performed a reverse rotation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie received one (1) nt411, (osseotite® tapered implant 4 x 11.5mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use.The implant's external hex was observed damaged/stripped.The implant was seen also damaged around the external threads likely due to the removal process.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2022030097.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 2022030097 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿damaged drive feature¿ the customer did submit two (2) images for the reported event.Based on the investigation and risk management file review as per rmf rm-00053-haz rev.12, the most likely root cause determined from the investigation is incorrect techniques used during implant placement - customer error.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was 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.The following sections have been updated: b4: date of this report, d9: device availability , g3: date received by manufacturer, g6: checked "follow-up", h2: checked follow-up type, h3: changed "no" to "yes", h6: entered evaluation codes, h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE TAPERED IMPLANT 4 X 11.5MM
• 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: 20029226
• Report Number: 0001038806-2024-01877
• Device Sequence Number: 18290294
• Product Code: DZE
• UDI-Device Identifier: 00844868012023
• UDI-Public: (01)00844868012023(17)270310(10)2022030097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: NT411
• Device Lot Number: 2022030097
• 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: 08/22/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic