MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 8.5MM; DENTAL IMPLANT

Catalog Number	INT485
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Osteolysis (2377)
Date of Event	04/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a bone loss and a infection at tooth site #25-27.Patient suffered pain and inflammation.Both implants were removed.
Additional Manufacturer Narrative
Zimvie complaint number cmp (b)(4) a1: patient identifier unknown / not provided a4: patient weight unknown / not provided d10.Concomitant medical products int410, osseotite tapered certain implant 4 x 10mm lot 2022071429 e1: reporter email address unknown / not provided h6: event problem codes ¿ patient code: 1932 inflammation.A summary investigation has been completed for bone loss and infection 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 and infection 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.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: OSSEOTITE TAPERED CERTAIN IMPLANT 4 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: 19445350
• Report Number: 0001038806-2024-01137
• Device Sequence Number: 18284441
• Product Code: DZE
• UDI-Device Identifier: 00844868006688
• UDI-Public: (01)00844868006688(17)280315(10)2023030125
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063341
• 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
• Report Date (Section B): 06/02/2024

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: INT485
• Device Lot Number: 2023030125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic