MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Catalog Number	XIFOSM311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: concomitant medical product and therapy dates: xifosm311, osseotite certain 2 implant 3.25 x 11.5mm, lot number: 2023031467.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
It was reported that the implants at tooth sites #32 & #42 were removed because it was discovered 3 weeks from implant placement date that the patient had a crestal abscess, clindamicina was prescribed and in a week a ct scan was done and apical lesions were also detected in both implants.Implants were removed due to apical infection.Symptoms as a result of the event: pain.Abscess.

• Brand Name: OSSEOTITE CERTAIN 2 IMPLANT 3.25 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: 18943315
• Report Number: 0001038806-2024-00500
• Device Sequence Number: 8381761
• Product Code: DZE
• UDI-Device Identifier: 00844868023098
• UDI-Public: (01)00844868023098(17)280414(10)2023031467
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100724
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/19/2024

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: XIFOSM311
• Device Lot Number: 2023031467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• 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: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic