MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 3.75 X 10MM; DENTAL IMPLANT

Model Number	XFOS310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2021-00975.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Doctor reports implant and prosthetic screw fractured on dental position: #46 without any negative effect on the patient.Implant was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite® 2 implant 3.75 x 10mm (xfos310) and one titanium hexed uniscrew (uniht) were returned for investigation.Visual inspection of the as returned products identified both implant and screw fractured at the middle threads.Additionally, some bone debris were present on the external threads.Device history record (dhr) review was completed for the subject lot number 2016011730.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 was performed for the reported lot number (2016011730) for similar event (keywords using fracture screw and fracture implant) and no other complaint was identified.Therefore, based on the available information, the reported device malfunction did occur and the event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE 2 IMPLANT 3.75 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11977532
• Report Number: 0001038806-2021-00974
• Device Sequence Number: 11822998
• Product Code: DZE
• UDI-Device Identifier: 00844868023784
• UDI-Public: (01)00844868023784(17)210204(10)2016011730
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2021
• Device Model Number: XFOS310
• Device Catalogue Number: XFOS310
• Device Lot Number: 2016011730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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