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

Catalog Number	XIFNT411
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.E1: reporter name unknown / not provided.
Event or Problem Description
It was reported that during the surgery on march 12th, when the blister pack was opened, the implant sticker was detached.No impact on the patient was reported, procedure was completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) xifnt411 (osseotite tapered certain implant 4 x 11.5 mm) for evaluation.Visual evaluation was performed.Customer only returned the implant's outer tray, and sterile inner tray for evaluation.The implant's outer box was not returned.The outer tray back seal was observed halfway opened, and the sterile inner tray was observed in a sealed condition.The coob is non-verifiable as the condition of the packaging/product delivered to the customer is unknown/non-verifiable.Device history record (dhr) review was completed for the subject lot number 2023030423.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 2023030423 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: packaging: other based on the investigation and risk management file review, the most likely root cause determined from the investigation was probably user caused.Therefore, based on the available information, a device malfunction could not be verified.Customer only returned the implant's outer tray, and sterile inner tray for evaluation.The implant's outer box was not returned.The outer tray back seal was observed halfway opened, and the sterile inner tray was observed in a sealed condition.The coob is non-verifiable as the condition of the packaging/product delivered to the customer is unknown / non-verifiable.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN 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: 21760362
• Report Number: 0001038806-2025-00743
• Device Sequence Number: 18258595
• Product Code: DZE
• UDI-Device Identifier: 00844868021964
• UDI-Public: (01)00844868021964(17)280317(10)2023030423
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/03/2025

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: Lay User/Patient
• Device Catalogue Number: XIFNT411
• Device Lot Number: 2023030423
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic