MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® 2 IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted to relay (b)(4).The reported device has been received for evaluation.Investigation is not complete once investigation has been completed.A follow up medwatch will be submitted.
Event or Problem Description
It was reported that during implant placement, the implant would not torque.The dr.Thought that the implant hex was rounded.The procedure was completed using another implant.There was no report of patient injury or delay in procedure.
Additional Manufacturer Narrative
The full osseotite 2 parallel walled certain implant (xifoss413) was returned for investigation.Visual inspection of the as returned implant identified minor signs of wear on the device.Through dimensional analysis and comparison to drawings, it was determined that the implant met design specifications.Functional testing with applicable cover screw and driver has revealed no malfunction with the returned device.The hex was still functioning.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.The device malfunction was unconfirmed.A root cause cannot be determined.The following sections have been updated: b4: date of this report.D4: device expiration.D4: (b)(4).G4: date received by manufacturer.G7: checked "follow-up." h2: checked follow-up type.H3: changed "no" to "yes." h4: date of manufacture.H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSSEOTITE® CERTAIN® 2 IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8925427
• Report Number: 0001038806-2019-00931
• Device Sequence Number: 290129
• Product Code: DZE
• UDI-Device Identifier: 00844868023166
• UDI-Public: (01)00844868023166(17)220602(10)2017051647(241)XIFOSS413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 06/15/2017
• Device Model Number: N/A
• Device Catalogue Number: XIFOSS413
• Device Lot Number: 2017051647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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