MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 3.25 X 8.5MM; DENTAL IMPLANT

Model Number	XFOSM385
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that the driver was not fitting inside the implant's drive feature and torque could not be achieved.The doctor confirms that the procedure was completed by placing another implant.The affected dental position is # 30.The doctor confirmed through a phone call that the driver works well with other implants and that's why it wasn't sent, and the lot number and reference number of the driver are unknown and impossible to obtain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Additional Manufacturer Narrative
Zimvie received one (1) xfosm385, (osseotite 2 implant 3.25 x 8.5mm) for evaluation.Visual evaluation was performed, the implant has signs of use, with bone debris on the external threads.There was observed damage around the implant's drive feature and platform.Dhr review was completed for the subject lot number 2022051232.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 2022051232 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : damaged drive feature¿.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz, the most likely root cause determined from the investigation was missing or confusing instructions for use or the torque or speed applied during placement/seating exceeded recommended value.Therefore, based on the available information, a device malfunction did occur.The implants drive feature was damaged.The reported event was confirmed.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.The following sections have been updated: h3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE 2 IMPLANT 3.25 X 8.5MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 17139871
• Report Number: 0001038806-2023-01169
• Device Sequence Number: 12205836
• Product Code: DZE
• UDI-Device Identifier: 00844868024064
• UDI-Public: (01)00844868024064(17)270527(10)2022051232
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/09/2023

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 Model Number: XFOSM385
• Device Catalogue Number: XFOSM385
• Device Lot Number: 2022051232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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 Age: 66 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic