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

Model Number	FOS511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported bad location for prosthesis.6 upper implants were placed for rehabilitation of posterior sites but the implant at tooth site 15 was in bad position and it made prosthetic rehabilitation very complicated.Implant was then removed and a new implant in better position was placed in the same surgery.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.H4: device manufacture date not available, lot number unknown.One implant were returned for investigation.Visual evaluation of the as returned product identified the implant removal tool fractured inside the implant.Implant has heavy sings of wear and damage possibly due to the removal process.Damage observed on returned implants due to trephine removal is not considered a malfunction or failure of the device.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was moderate bone density (type ii).Patient is a smoker and bruxist.The reported device was located on tooth 15 (fdi) and was used for approximately 5 months, and 28 days.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: p-iis086gi rev.H - 07/2021; potential adverse events; page 3.& instructions for use - retriever tools and guide sleeves, ifu 4930i rev 3 ¿ 11/19.Information identified: indications, warnings and precautions.Per the applicable ifu, it is stated that surgical instruments are susceptible to damage and wear and should be inspected and cleaned before each use.Dhr review: dhr review was completed for the subject lot number (2018070391).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 dhr.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product is within specifications.Complaint history review : review completed utilizing keywords: 'functional fracture, functional other' complaint history review was performed for the reported lot number (2018070391) for similar events and no other complaint was identified.Review completed utilizing keywords: 'functional other' post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported events (functional fracture, functional other) or product (fos511, irt).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, the reported event for the implant (functional other: bad position) could not be verified as the exact details of event and patient anatomical conditions were unknown.

• Brand Name: FULL OSSEOTITE® 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: 13341833
• Report Number: 0001038806-2022-00101
• Device Sequence Number: 14481001
• Product Code: DZE
• UDI-Device Identifier: 00844868003731
• UDI-Public: (01)00844868003731(17)230725(10)2018070391
• 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: 2021
• 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): 05/05/2022

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: 07/25/2023
• Device Model Number: FOS511
• Device Catalogue Number: FOS511
• Device Lot Number: 2018070391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female