MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® 2 IMPLANT 6 X 11.5MM; DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).The reported device has been received for evaluation.The investigation has not yet begun.Once the investigation has been completed, a follow up medwatch will be submitted.(b)(6).
Event or Problem Description
It was reported that the implant got stuck at tooth location #30.The implant did not seat all the way.The implant was damaged while trying to remove it and some bone was removed.The site was grafted and buccal bone removed.The procedure was completed during the same procedure.The second implant placement was successful.
Additional Manufacturer Narrative
This report is being submitted to relay additional and corrected information.The following sections are being reported: b1: correction: product problem b5: it was reported that the implant got stuck at tooth location #19.The implant did not seat all the way.The implant was damaged while trying to remove it and some bone was removed.The site was grafted and buccal bone removed.The procedure was completed during the same procedure.The second implant placement was successful.D4: expiration date: 16 jun 2022.Udi: (b)(4).G3: correction: company representative.G4: 10 jun 2019.H4: correction: 27 jun 2017.H6:correction: device code: 2547.The reported device was received for evaluation.Visual inspection identified the implant is damaged from removal at the connection point of the implant.The reported condition of an implant that got stuck could not be confirmed.A device history record (dhr) review was completed for the reported device lot number.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 were noted as part of the dhr.A complaint history review was completed for the reported device lot number for similar events and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the implant got stuck at tooth location #19.The implant did not seat all the way.The implant was damaged while trying to remove it and some bone was removed.The site was grafted and buccal bone removed.The procedure was completed during the same procedure.The second implant placement was successful.

• Brand Name: OSSEOTITE® CERTAIN® 2 IMPLANT 6 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8628771
• Report Number: 0001038806-2019-00434
• Device Sequence Number: 2232544
• Product Code: DZE
• UDI-Device Identifier: 00844868023272
• UDI-Public: (01)00844868023272(17)220616(10)2017060139(241)XIFOSS611
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 06/16/2022
• Device Model Number: N/A
• Device Catalogue Number: XIFOSS611
• Device Lot Number: 2017060139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Weight: 68