MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM; DENTAL ABUTMENT

Model Number	ILDAT5
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
Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Gender unknown / not provided.Patient weight unknown / not provided.Date of event unknown / not provided.Device expiration date unknown / not provided.Last name unknown / not provided.
Event or Problem Description
It was reported that the abutment will not stay in mouth, not just the screw, but the abutment.The patient is being referred to the surgeon to review the implant.Tooth- 19.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One certain® bellatek® titanium abutment 5.0mm, ildat5 with crown attached, was returned for investigation.Visual inspection via naked eye and camera magnification revealed no damage or manufacturing deviations which could cause or contribute to the reported event.The abutment was seated on an in-house implant without any hindrance.The unknown iunihg screw was not returned.Appropriate documentation was reviewed.Review of the digital design files was performed.Lda abutments are scanned and designed within the lab.Zimmer biomet only mills the design received through 3shape software.Therefore, a comparison between the customer design and the product should be performed.As the returned abutment has a crown attached the abutment export milling file was also used for the comparison (image iii).No discrepancies were observed.Device history record (dhr) review was completed for the subject lot number (8625501-1).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.A dhr review could not be performed as the lot number associated with the reported screw (iunihg) was not available ¿ the screw in this complaint is not the one bundled with the abutment as it was not the original screw.A complaint history review by item number was conducted for the iunihg dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events a lot specific complaint history review is not conducted for psp complaints as patient specific products have a unique one time use lot number.Based on the available information, abutment malfunction did not occur.

• Brand Name: CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM
• 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: 12350810
• Report Number: 0001038806-2021-01584
• Device Sequence Number: 19928893
• Product Code: NHA
• UDI-Device Identifier: 00844868031413
• UDI-Public: (01)00844868031413(10)8625501-1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K052648
• 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): 12/16/2021

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 Model Number: ILDAT5
• Device Catalogue Number: ILDAT5
• Device Lot Number: 8625501-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• 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: 07/29/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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 Sex: Prefer Not To Disclose