MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)

Model Number	IEHA444
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Implant date unknown / not provided.Explant date unknown / not provided.Email unknown / not provided.
Event or Problem Description
It was reported that clinician placed a second implant at site 4 with insertion torque 20ncm.Clinician completed 2nd stage for implant on (b)(6) 2019 and to doctor's knowledge there no issues seating the healing abutment.General dentist sent patient back to clinician him to reseat the healing abutment on (b)(6) 2020 as it was not seating back in implant.
Additional Manufacturer Narrative
One 3i t3® non-platform switched tapered implant (bost411) and one certain® bellatek® encode® healing abutment were returned for investigation.Visual evaluation of the as returned devices identified bone residue around the external threads of the implant and cuts/signs of wear on the abutment due to usage (images 1 ¿ 5).Additionally, the implant¿s drive feature was damaged.Customer reported two separate sets of event with products; this investigation covers the first one according to which the general dentist could not re-seat the abutment and the patient was sent back to dr.Horne.Functional testing was performed and the healing abutment was able to engaged into the implant as normal (image 4).Pre-existing condition noted on the per was low bone density ¿ type iii.The implant had been placed on tooth # 4 (universal) for approximately 1 year (jan 2019 ¿ feb 2020) when the incident occurred.X-ray or picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lots (2018061048 & 1217004) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lots (2018061048 & 1217004) for similar event and one other complaint (b)(4) was identified.Based on the available information, implant malfunction (damaged drive feature) did occur.However, abutment malfunction did not occur and the reported event (does not seat) was unconfirmed following functional testing.The following sections have been updated: g7: checked "follow-up." h3: changed "no" to "yes.".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10226008
• Report Number: 0001038806-2020-00923
• Device Sequence Number: 514997
• Product Code: NHA
• UDI-Device Identifier: 00844868004608
• UDI-Public: (01)00844868004608(17)230619(10)1217004(241)IEHA444
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2020

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: 06/19/2023
• Device Model Number: IEHA444
• Device Catalogue Number: IEHA444
• Device Lot Number: 1217004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 09/27/2020
• 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: 70 YR