MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Catalog Number	NT585
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.
Event or Problem Description
Doctor reported sinus relocation at tooth site 27.One implant biomet 5 x 8.5 mm was placed in autologous bone.On (b)(6) 2024 when checking on implant's integration at tooth site 27 doctor noticed that implant is in the area of the sinus membrane surrounded by bone graft.On (b)(6) 2024 implant was removed and a new biomet nt585 was placed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) nt585, (nanotite tapered certain® implant 5 x 8.5 - 15mm) for evaluation.Visual evaluation was performed.Product inspected and filed.Implant was returned with no damage that would cause or contribute to the event.Measurements match drawing.Device history record (dhr) review was completed for the subject lot number 2022060091.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 2022060091 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: medical: relocation into sinus.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was user error/patient factors.Therefore, based on the available information, a device malfunction did not occur.Implant was returned with no damage that would cause or contribute to the event.The reported event could not be verified with all the available 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¿ TAPERED IMPLANT 5 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18921007
• Report Number: 0001038806-2024-00475
• Device Sequence Number: 6189018
• Product Code: DZE
• UDI-Device Identifier: 00844868012108
• UDI-Public: (01)00844868012108(17)270613(10)2022060091
• 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: 2023
• 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): 08/25/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: NT585
• Device Lot Number: 2022060091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• 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
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• 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: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic