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

Model Number	FOS313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant fos313 fractured and was removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.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.H10: additional narrative.One full osseotite® implant 3.75 x 13mm (fos313) was returned for investigation.Visual evaluation of the as returned product identified signs of wear and debris about the implant threads.There are no signs of fracture.No pre-existing conditions were noted on the per.The reported product was located on an unknown tooth site and used for approximately 6.5 years prior to the notification date.The reported event could not be recreated due to the nature of the dental device and event (fracture).Device history record (dhr) review was completed for the subject lot number 2012090508.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 (2012090508) for similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has not occurred and the reported event was unconfirmed.

• Brand Name: FULL OSSEOTITE IMPLANT 3.75 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10325094
• Report Number: 0001038806-2020-01029
• Device Sequence Number: 17049783
• Product Code: DZE
• UDI-Device Identifier: 00844868003502
• UDI-Public: (01)00844868003502(17)170913(10)2012090508(241)FOS313
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 09/13/2017
• Device Model Number: FOS313
• Device Catalogue Number: FOS313
• Device Lot Number: 2012090508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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