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 Code	Sinus Perforation (2277)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A1: patient identifier unknown / not provided.D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that the implant was placed at tooth site 26 with a small sinus perforation.Implant achieved good primary stability.On (b)(6) 2023 implant lost integration due to infection and was removed ((b)(4)).Pain and edema were reported as a result of the event.Patient will return in september to place a new implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) int485, (osseotite tapered certain implant 4 x 8.5mm) for evaluation.Visual evaluation was performed, the implant had marking due to the removal process.There were no signs of malfunction that would contribute to the event.The implant matched print specifications.The implant was measured by using caliper.Dhr review was completed for the subject lot number 2022090756.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 2022090756 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : perforated sinus.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was missing or confusing instructions for use or inadequate treatment planning.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was 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.
Event or Problem Description
No further event information is available at the time of this report.

• 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: susanne taylor ; 4555 riverside drive; palm beach gardens 33410 ; 5619713230
• MDR Report Key: 17315672
• Report Number: 0001038806-2023-01292
• Device Sequence Number: 17133078
• Product Code: DZE
• UDI-Device Identifier: 00844868006688
• UDI-Public: (01)00844868006688(17)270928(10)2022090756
• 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: 2023
• 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): 11/14/2023

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: 2022090756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• 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: 07/13/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic