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

Model Number	FNT3211
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the implants in tooth location # 10, 12 and 14 were removed due to allergic reaction.Patient came to the clinic with pain, an abscess and the site had inflammation.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem 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 one full osseotite® tapered implant 3.25 x 11.5mm (fnt3211), one full osseotite® tapered implant 4 x 10mm (fnt410) and one 3i t3® ex hex tapered implant 4 x 10mm (boet410) were returned for investigation.Visual evaluation of the as returned products identified no apparent malfunction, dried blood and bone debris present on the external threads and some wear/damage to the threads, likely from the retrieval process.Pre-existing conditions noted on the per were low bone density (type iv), deficient oral hygiene and a smoker.The reported devices were located on tooth # 22, 24 & 26 (fdi) and were implanted for approximately 5 months.The customer reported the patient had pain, inflammation and abscess, which will not be investigated as they are symptoms of the allergic reaction event.The customer did not provide pictures, x-rays or patient allergy report.Device history record (dhr) reviews were completed for the subject lot numbers (2019031342, 2019021302 & 2019050657).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhrs.Lots were inspected and passed all acceptance criteria by qa.Complaint history reviews were performed for the reported lot numbers (2019031342, 2019021302 & 2019050657) for similar events and no other complaint was identified.Therefore, based on the available information, device malfunction did not occur and the reported event was non-verifiable for all reported devices as not enough information was provided to confirm the patient¿s allergy.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11002568
• Report Number: 0001038806-2020-02058
• Device Sequence Number: 16341488
• Product Code: DZE
• UDI-Device Identifier: 00844868003281
• UDI-Public: (01)00844868003281(17)240402(10)2019031342(241)FNT3211
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 04/02/2024
• Device Model Number: FNT3211
• Device Catalogue Number: FNT3211
• Device Lot Number: 2019031342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR