MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE 2 IMPLANT 3.75 X 11.5MM; DENTAL IMPLANT

Model Number	XFOS311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2016
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 xfos311 in dental site 19 fractured and was removed.A new implant would be place.
Additional Manufacturer Narrative
The device was not returned for evaluation.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A root cause cannot be determined.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp-(b)(4).One osseotite® 2 implant 3.75 x 11.5mm (xfos311) was returned for evaluation.Review of the returned product notes that the device is fractured in half at the collar and the threads are badly worn.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 2013100903.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.Therefore, based on the available information, device malfunction has not occurred and the reported 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 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9980345
• Report Number: 0001038806-2020-00726
• Device Sequence Number: 4356349
• Product Code: DZE
• UDI-Device Identifier: 00844868023791
• UDI-Public: (01)00844868023791(17)181029(10)2013100903(241)XFOS311
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2020

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: 10/29/2018
• Device Model Number: XFOS311
• Device Catalogue Number: XFOS311
• Device Lot Number: 2013100903
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 08/11/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 06/15/2020; 09/04/2020
• 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
• Patient Age: 52 YR