MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 3.75 X 11.5MM; DENTAL IMPLANT

Catalog Number	OSS311
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that the implant¿s packaging was open, with the mounting device detached from the implant.Doctor confirmed that the event was discovered at the exact moment of unpacking the product.No impact on the patient's health.
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.D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information d9: device availability g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative the doctor reports that the implant¿s packaging was open, with the mounting device detached from the implant.The called on (b)(6) 2025 and confirmed that the event was discovered at the exact moment of unpacking the product.Zimvie received one (1) oss311, (osseotite implant 3.75 x 11.5mm) for evaluation.Visual inspection was performed.No mount returned and no damage to the implant was identified that would cause or contribute to the event.Cal4063 due (b)(6) 2025.The coob is non-verifiable as the condition of the implant / packaging when received by the customer is unknown / non-verifiable dhr review was completed for the subject lot number 2120012926.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 2120012926 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: packaging: damaged or un-sealed sterile barrier.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was incorrect handling by end user.Therefore, based on the available information, a device malfunction could not be verified.The returned implant packaging box and mount were not returned and no damage to the implant was identified that would cause or contribute to the event.The coob is non-verifiable as the condition of the implant / packaging when received by 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 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 IMPLANT 3.75 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: 21552933
• Report Number: 0001038806-2025-00508
• Device Sequence Number: 18199845
• Product Code: DZE
• UDI-Device Identifier: 00844868013112
• UDI-Public: (01)00844868013112(17)290422(10)2120012926
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063286
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: OSS311
• Device Lot Number: 2120012926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2025
• 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: 03/07/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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