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

Catalog Number	OSS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Discomfort (2330); Osteolysis (2377)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient went to the dentist office due to discomfort and mobility from implants at tooth site #35-36.During the checkup, it was detected that there was slight bone loss and both implants were fractured at the bottom and the collar.Implants were completely removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.D10.Concomitant medical products oss411, osseotite implant 4 x 11.5mm lot 2016060690.
Additional Manufacturer Narrative
Zimvie 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) oss411 (osseotite implant 4 x 11.5mm) for evaluation.Visual evaluation was performed, the implant had signs of use with bone debris on its external threads.The implant trephined and was fractured at the collar.Device history record (dhr) review was completed for the subject lot number 2016060690.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 2016060690 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: dental: medical: bone loss and dental: functional: fracture: implant based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors.Summary investigation for bone loss: a summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Therefore, based on the available information, a device malfunction did occur.The implant was fractured at the collar.The reported event was confirmed.Bone loss is a medical condition and is non-verifiable with all the information.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 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: 21959665
• Report Number: 0001038806-2025-00982
• Device Sequence Number: 7273294
• Product Code: DZE
• UDI-Device Identifier: 00844868013181
• UDI-Public: (01)00844868013181(17)210617(10)2016060690
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 07/22/2025

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 Expiration Date: 06/16/2021
• Device Catalogue Number: OSS411
• Device Lot Number: 2016060690
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2025
• 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: 05/05/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic