MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H); DENTAL ABUTMENT

Model Number	IEHA564
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the abutment was not able to be seated on the implant.We were able to place another healing abutment the same size that day which worked fine.Tooth 31.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report; d4: catalog number; d4: lot/serial # ; d4: device expiration date ; d4: device udi number; g3: date received by manufacturer; g6: checked "follow-up"; h2: checked follow-up type; h4: device manufacturer date; h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One (1) certainâ® bellatekâ® encodeâ® healing abutment 5mm(d) x 6mm(p) x 4mm(h) (ieha564) was returned for investigation.Visual evaluation of the as returned product identified the abutment, with original packaging.Signs of use, scratches were noted.During a functional test with an in-house implant, the abutment seated as intended.Abutment matched prints where measured.A pre-existing condition noted on the per was moderate bone density (type ii), diabetes.The reported device was located on tooth # 31 (universal) and was used for approximately 2 months, 19 days.The customer did not provide any pictures or x-rays.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1213382).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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1213382) for similar events and no other complaint was identified.November post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not seat) or product (ieha564).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur and the reported event was non-verifiable without return of all items / devices involved.The following sections have been updated: g6: 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 5MM(D) X 6MM(P) X 4MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15189409
• Report Number: 0001038806-2022-01211
• Device Sequence Number: 14861339
• Product Code: NHA
• UDI-Device Identifier: 00844868004806
• UDI-Public: (01)00844868004806(17)230219(10)1213382
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2023

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: 02/19/2023
• Device Model Number: IEHA564
• Device Catalogue Number: IEHA564
• Device Lot Number: 1213382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 01/09/2023
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 12/12/2022; 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 98 KG