MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H); DENTAL HEALING ABUTMENT

Model Number	IEHA354
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported that the abutment screw does not screw.Procedure was completed with another healing abutment.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One certain® bellatek® encode® healing abutment (ieha354) was returned for investigation.Visual evaluation of the as returned product identified that it was in good condition.The returned device was functionally tested with an in-house implant.The devices were able to engage and disengage successfully.No pre-existing conditions were noted.The device had been placed on an unknown tooth location for an unknown amount of time.X-ray & picture images were not provided by the customer.The dhr was not available electronically for the subject lot number (1236147) thus could not be further reviewed at the time of the investigation.A notification to manufacturing has been sent and requested to pull the dhr for review.The pce will be reopened and updated if there is any indication of non- conformance, or any possible manufacturing issue related to the reported event.Since the dhr was not available, a search in the nonconformance database (tipqa) was conducted with the lot number to discover any non-conformances related to the reported event and subject lot number.No non-conformances were found for the subject lot number.Complaint history review was performed for the reported lot (1236147) and no similar event or complaint was found.July post market trending was reviewed and there were no actionable trends or corrective actions for the reported event or device.Therefore, based on the available information and functional testing, device malfunction did not occur.Additionally, the reported event could not be verified as the implant involved was unknown and not returned.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H)
• Common Device Name: DENTAL HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10199693
• Report Number: 0001038806-2020-00895
• Device Sequence Number: 1072429
• Product Code: NHA
• UDI-Device Identifier: 00844868004561
• UDI-Public: (01)00844868004561(17)250216(10)1236147(241)IEHA354
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2025
• Device Model Number: IEHA354
• Device Catalogue Number: IEHA354
• Device Lot Number: 1236147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1