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

Model Number	IEHA443
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant at tooth location #5 was placed with slight simultaneous bone graft at buccal.Since high primary stability was obtained, the healing abutment was put on top directly.The patient has malsensation, not necessarily pain, over the area all the time.Four (4) weeks after, the healing abutment fell off and the patient came into the office to tighten the healing abutment back on.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation code was added: 10, 3331, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67.H10: narrative/data was updated.One certain® bellatek® encode® healing abutment 4.1mm(d) x 4.1mm(p) x 3mm(h) (ieha443) and one full osseotite® tapered certain® implant 4 x 10mm (ifnt410) were returned for investigation.Visual evaluation of the returned product identified no apparent malfunction.Signs of use and dried blood on the implant external threads.Functional testing was performed and abutment seated normally to the returned implant.Pre-existing condition as noted on per was type ii (moderate) bone density.The device had been placed on a tooth location #5 (universal) for approximately 9 months.Per the applicable ifu, under section precautions, it is stated that improper technique could cause screw loosening.Dhr review was completed for the subject lot number (1218207 and 2019051213).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 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 (1218207 and 2019051213) for similar event using keyword functional loosening and no other complaint was identified.October post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional: loosening) or products.Therefore, based on the available information, device malfunction has not occurred and the reported events could not be verified as the exact details of event were non-verifiable.
Event or Problem Description
No additional event information at the time of this report.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(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: 12263753
• Report Number: 0001038806-2021-01427
• Device Sequence Number: 14602398
• Product Code: NHA
• UDI-Device Identifier: 00844868004592
• UDI-Public: (01)00844868004592(17)230718(10)1218207
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: Lay User/Patient
• Device Expiration Date: 07/18/2023
• Device Model Number: IEHA443
• Device Catalogue Number: IEHA443
• Device Lot Number: 1218207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• 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: 07/13/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2018
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT-.
• Patient Sex: Male