MAUDE Adverse Event Report: BIOMET 3I 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 11.5MM; DENTAL IMPLANT

Model Number	BOES3711
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the bridge from ttoh location 7 to 9 was loose, fracture was noticed after the removal of brigde.Fractured part of the implant was removed.Patient referred pain and has been rescheduled for new implant placement and new suprastructure.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes' one 3i t3® ex hex parallel walled implant 3.75 x 11.5mm (boes3711) was returned for investigation.Visual evaluation of the as returned product identified significant signs of wear from use, and fracture laterally across the threads.The patient is noted to have a history of clenching.The reported product was located on tooth # 11 (fdi) and used for approximately 2.5 years.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 2016061490.It was confirmed that all operations and inspections were executed as per the 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 was performed for the reported lot number (2016061490) for a similar event and no other complaint was identified.Therefore, based on the available information, device malfunction has 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: 3I T3® EX HEX PARALLEL WALLED 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: 9835784
• Report Number: 0001038806-2020-00505
• Device Sequence Number: 16903395
• Product Code: DZE
• UDI-Device Identifier: 00844868032373
• UDI-Public: (01)00844868032373(17)210627(10)2016061490(241)BOES3711
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: Health Professional
• Device Expiration Date: 06/27/2021
• Device Model Number: BOES3711
• Device Catalogue Number: BOES3711
• Device Lot Number: 2016061490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/14/2020
• 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: 63 YR
• Patient Weight: 75