MAUDE Adverse Event Report: BIOMET 3I 3I T3® EX HEX TAPERED IMPLANT 4 X 13MM; TAPERED DENTAL IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).The following information is unknown at the time of this report: reporter last name not provided.The device has been received for evaluation.Investigation has not yet begun.Once investigation has been completed, a follow up medwatch will be submitted.
Event or Problem Description
It was reported that the patient presented with infection and bone loss at tooth location #12.The implant was removed.There was no report of patient injury.
Additional Manufacturer Narrative
One tapered implant (boet413) and cover screw were returned for investigation.Visual inspection of the as returned products identified no physical damage.The cover screw was attached to the implant.Per functional testing, the cover screw was able to be removed from the implant and there was no sign of malfunction.Measurements were taken and through dimensional analysis and comparison to drawings, it was determined that the products were within design specifications.No pre-existing conditions were noted on the per.The reported products were located on tooth #12 and were used for approximately 4 months.Pictures or x-ray images were not provided.As a result, bone loss could not be verified.Dhr review for the lot (2017021540) had revealed no deviations nor non-conformances which could have caused or contributed to bone loss and infection after implantation.All products were conforming at the time they left zimmer biomet.In addition, all sterilization activities were conducted with no nonconformities per sterilization record (op# 0210).Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review was performed for the reported lot (2017021540) and no similar event or complaint was found.June monthly post market trending was reviewed and there were no negative trends or corrective actions for bone loss, infection or the returned products (boet413).Therefore, based on the available information, device malfunction did not occur and the event could not be verified through visual inspection of the returned products.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3® EX HEX TAPERED IMPLANT 4 X 13MM
• Common Device Name: TAPERED DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8708336
• Report Number: 0001038806-2019-00519
• Device Sequence Number: 11285340
• Product Code: DZE
• UDI-Device Identifier: 00844868033271
• UDI-Public: (01)00844868033271(17)220306(10)2017021540(241)BOET413
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133049
• 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): 10/03/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: N/A
• Device Catalogue Number: BOET413
• Device Lot Number: 2017021540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention