MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM; DENTAL IMPLANT

Catalog Number XIFNT410

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 11/26/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

Doctor reported implant removed due to fracture.Pain reported as a consequence of the event.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).H3: device evaluated by manufacturer: change ¿no' to 'yes'.An implant and screw were returned for investigation in the complaint.Visual inspection of the as returned products identified worn markings due to usage, excessive bone/debris and a fracture on the collar and a screw fractured (screw inside implant).Pre-existing conditions were noted on the per was smoker/tobacco use.The reported device location is unknown and was used for approximately 6 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'.Documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f ¿ october 2019 information identified: 'warnings' 'precautions' 'potential adverse events'.Dhr review: dhr review was completed for the subject lot number (2015060467).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.Dhr review could not be performed, as the lot number associated with the reported iuniht product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review: complaint history review was performed for the reported lot number (2015060467) for similar event and no other complaint was identified.A complaint history review by item number was conducted for the (iuniht) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Review completed utilizing keywords: fracture : implant and fracture : screw 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® TAPERED CERTAIN® IMPLANT 4 X 10MM
• 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: 13597089
• MDR Text Key: 286119535
• Report Number: 0001038806-2022-00276
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K130949
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2020
• Device Catalogue Number: XIFNT410
• Device Lot Number: 2015060467
• 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
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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 Sex: Male