MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® IMPLANT 3.75 X 13MM; DENTAL IMPLANT

Catalog Number OSS313

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported the implant fractured at the body and was removed.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes'.A osseotite® implant 3.75 x 13mm (oss313) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and fracture at the collar.No pre-existing conditions were noted on the per.The reported device was located on tooth 12 and was used for approximately 11 years.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev i - 2022/04/01 information identified: 'warnings' 'precautions' 'potential adverse events'.Dhr review: dhr review was completed for the subject lot number (2008080058).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2008080058) for similar event and no other complaint was identified.Review completed utilizing keywords: "functional : fracture : implant.Post market trend review: june post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did occur and the reported event was confirmed.

Event Description

No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® IMPLANT 3.75 X 13MM
• Type of Device: 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: 13597179
• MDR Text Key: 286115104
• Report Number: 0001038806-2022-00278
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: OSS313
• Device Lot Number: 2008080058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female