MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 3.25 X 13MM; DENTAL IMPLANT

Catalog Number	XIFNT3213
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.B3: date of event: unknown / not provided.E1: reporter name: unknown / not provided.
Event or Problem Description
It was reported that there was a different implant than the one indicated on the label.No impact on the patient was reported.The process was completed with another implant.
Additional Manufacturer Narrative
Imvie 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.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) xifnt3213, (osseotite tapered certain implant 3.25 x 13mm) for evaluation.A visual evaluation was performed, the returned implant outer box was observed opened and its tamper seal was broken.The implant's outer box was identified as reported; however, the outer tray was missing / not returned.The sterile inner tray was also opened but the label was identified as xiitp4313 lot # 2120006196.The returned implant (xiitp4313) has signs of use, apparent dried blood attached to external threads, and matched prints where measured.Device history record (dhr) review was completed for the subject lot number 2022100240.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 2022100240 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : packaging : incorrect product based on the investigation and risk management file review, the most likely root cause determined was improper handling of product outside of zimvie controls.Therefore, based on the available information, a packaging malfunction could not be verified.The implants outer box packaging tamper seal was broken.The sterile inner tray was also opened but was for a different size implant.The implant also appeared to have signs of use.The reported event/coob is non-verifiable since the condition of the product/packaging received by the customer was unknown.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 3.25 X 13MM
• 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: 22034786
• Report Number: 0001038806-2025-01089
• Device Sequence Number: 15823541
• Product Code: DZE
• UDI-Device Identifier: 00844868021902
• UDI-Public: (01)00844868021902(17)271019(10)2022100240
• 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): 08/18/2025

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: Other
• Device Catalogue Number: XIFNT3213
• Device Lot Number: 2022100240
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/08/2025
• 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: 05/16/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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