MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	IOSS411
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	12/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, under antibiotic coverage, two identical and adjacent implants were placed in the posterior jaw with excellent primary stability.Two days after the intervention, the patient feels unwell (possibly an allergic reaction) and, following the advice of the primary physician, discontinues antibiotic intake.After a month, the patient returns with abscess-like symptoms, and one of the two implants is mobile in an expulsion phase.The doctor reports pain.The doctor confirms that the procedure was not completed by placing another implants.Dental position affected: #46.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10: concomitant medical product and therapy dates k063341, osseotite® certain® implant 4 x 11.5mm, lot number: 2016070089.
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: zimvie did not receive one (1) ioss411, (osseotite certain implant 4 x 11.5mm) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 2016070089.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 2016070089 for similar events and 1 other relevant complaint(s) was identified.Review completed utilizing keywords: dental: medical: allergic reaction.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning and material selection.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.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.H3 other text : product not returned.

• Brand Name: OSSEOTITE CERTAIN IMPLANT 4 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18343400
• Report Number: 0001038806-2023-02460
• Device Sequence Number: 12883946
• Product Code: DZE
• UDI-Device Identifier: 00844868007098
• UDI-Public: (01)00844868007098(17)210711(10)2016070089
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• 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): 05/16/2024

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 Expiration Date: 07/10/2021
• Device Catalogue Number: IOSS411
• Device Lot Number: 2016070089
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2016
• 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; DENTAL IMPLANT
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic