MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN 2 IMPLANT 5 X 15MM; DENTAL IMPLANT

Model Number	XIFOSS515
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that when the doctor was placing the implant it got stuck 2/3 of the way down.The doctor attempted to seat it further with no resolve and after attempting to remove the implant and being unsuccessful he cut off the top of the implant and bury it.New implant was placed at an adjacent site.Tooth #29.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
The osseotite® certain® 2 implant 5 x 15mm (xifoss515) was not returned for investigation.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported implant was located on tooth #29 site and remains implanted.The reported event could not be recreated due to the nature of the dental device and event (damaged).The customer has not provided additional pictures or x-ray images of the product.Dhr review: dhr review was completed for the subject lot numbers 2016030747.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: complaint history review was performed for the reported lot numbers (2016030747) for similar event and no other complaint was identified utilizing keyword(s) damage.Post market trend review: may post market trending was reviewed and there were no actionable events or corrective actions for the reported event(s) (damaged threads) or product (xifoss515) therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.

• Brand Name: OSSEOTITE CERTAIN 2 IMPLANT 5 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11604321
• Report Number: 0001038806-2021-00541
• Device Sequence Number: 4455264
• Product Code: DZE
• UDI-Device Identifier: 00844868023241
• UDI-Public: (01)00844868023241(17)210318(10)2016030747
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: XIFOSS515
• Device Catalogue Number: XIFOSS515
• Device Lot Number: 2016030747
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1