MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Model Number	XFOS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Email address was not provided.
Event or Problem Description
It was reported that the implant at tooth site 19 fractured at the neck portion.Additional appointment required: yes, to remove and place a new implant.Bottom part remains implanted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp- (b)(4).The following sections have been updated: b4: date of this report; b5: describe event or problem; d4: unique identifier (udi) number changed to unknown; g4: date received by manufacturer; g7: type of report, follow-up number; h1: type of reportable event; h2: follow up type; h3: device evaluated by manufacturer; h6: event problem and evaluation codes.One osseotite® implant (xfos411) was returned for investigation.Visual evaluation of the as returned product identified, that only the top portion of the device was returned fractured.Device history record (dhr) review was completed for the subject lot number#: (2011101977).It was confirmed, that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted, as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was completed for the subject lot number (2011101977).And no other complaint was identified.Therefore, based on the available information, device malfunction did occur.And the reported event was confirmed.

• Brand Name: OSSEOTITE 2 IMPLANT 4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10883683
• Report Number: 0001038806-2020-01877
• Device Sequence Number: 14266375
• Product Code: DZE
• UDI-Device Identifier: 00844868023852
• UDI-Public: (01)00844868023852(17)161114(10)2011101977(241)XFOS411
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: Lay User/Patient
• Device Expiration Date: 11/14/2016
• Device Model Number: XFOS411
• Device Catalogue Number: XFOS411
• Device Lot Number: 2011101977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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: 42 YR