MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED IMPLANT 4 X 10MM; DENTAL IMPLANT

Catalog Number	FNT410
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
After follow up, doctor confirmed that during implant placement, it disengage from the mount and fell on patient face.Patient would have to return to place a new implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).This report is submitted to correct b1 to adverse event and h1.Type of reportable event: to serious injury.
Event or Problem Description
No further event information is available at the time of this report.
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.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.Zimvie received one (1) fnt410, (full osseotite tapered implant 4 x 10mm) for evaluation.Visual evaluation and a functional test were performed, the implants packaging was not returned with the implant.The implant had signs of use, with bone debris on external threads.The reported transfer mount was not returned with the implant for investigation.Unable to functionally test the two devices.The implants measurements matched drawing.Device history record (dhr) review was completed for the subject lot number 2023021068.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 2023021068 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : disengaged.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the clinician did not follow recommended protocol for attaching implant mount to implant.Therefore, based on the available information, a device malfunction could not be verified.The reported transfer mount was not returned with the implant for investigation.The reported event/coob was 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE TAPERED IMPLANT 4 X 10MM
• 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: 19358307
• Report Number: 0001038806-2024-01043
• Device Sequence Number: 17086348
• Product Code: DZE
• UDI-Device Identifier: 00844868003328
• UDI-Public: (01)00844868003328(17)280228(10)2023021068
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

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: Health Professional
• Device Catalogue Number: FNT410
• Device Lot Number: 2023021068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• 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; Not provided
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/28/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic