MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Model Number	NT511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sinus Perforation (2277); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Additional device information unknown / not provided.
Event or Problem Description
Patient has oral-antral communication.Antibiotics prescribed.Implant removed, using soft tissue punch first.Sutures placed #26.He also reported stiffness opening mouth.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information d9: device availability g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative zimvie receives (1) osseotite tapered implant, (nt511) for investigation.Visual/physical evaluation of the as returned product identified signs of use but no apparent signs of malfunction.Dhr review was completed for the subject lot number 2017080162.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 2017080162 for similar events and no other complaint was identified.Review completed utilizing keywords: medical: perforated sinus.Therefore, based on the available information, device malfunction could not be verified.Additionally, the reported event could not be verified as the exact details of event were unknown/unverifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE¿ TAPERED IMPLANT 5 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 ; 5617766700
• MDR Report Key: 16659197
• Report Number: 0001038806-2023-00649
• Device Sequence Number: 15244053
• Product Code: DZE
• UDI-Device Identifier: 00844868012078
• UDI-Public: (01)00844868012078(17)220831(10)2017080162
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/22/2023

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: Other
• Device Expiration Date: 08/30/2022
• Device Model Number: NT511
• Device Catalogue Number: NT511
• Device Lot Number: 2017080162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic