MAUDE Adverse Event Report: BIOMET 3I CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)

Model Number	IEHA464
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Customer reported that he tried healing abutment in 2 different patients, but would not seat.Doctor placed one-piece healing abutment to complete procedure.
Additional Manufacturer Narrative
Certain® bellatek® encode® healing abutment 4.1mm(d) x 6mm(p) x 4mm(h) ieha464 was returned for investigation, visual inspection of the as returned product identified worn markings due to usage.No damage.A osseotite® tapered certain® prevail® implant 5/4 x 8.5mm (xiitp5485) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.The customer did not claim any issues with xiitp5485.Procedure completed using another healing abutment.No malfunction with implant.No further investigation will be conducted for xiitp5485.Functional testing was performed for the returned products with an in-house stock device and performed as intended.No malfunction identified.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.Pictures or x-ray images were not provided.Appropriate documentation was removed.Dhr review was completed for the subject lot number (1238704).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 (1238704) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event was unconfirmed.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.
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 6MM(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: 11211551
• Report Number: 0001038806-2021-00097
• Device Sequence Number: 3805719
• Product Code: NHA
• UDI-Device Identifier: 00844868004684
• UDI-Public: (01)00844868004684(17)250915(10)1238704(241)IEHA464
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/29/2021

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: Health Professional
• Device Expiration Date: 09/15/2025
• Device Model Number: IEHA464
• Device Catalogue Number: IEHA464
• Device Lot Number: 1238704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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