MAUDE Adverse Event Report: BIOMET 3I BELLATEK TITANIUM ABUTMENT 4.1MM; DENTAL ABUTMENT

Catalog Number	LDAT4
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient called in to advise implant that was implanted in site 18/19 in 1995 was a 4.1x11 (implant was a 4.1x13) the abutment broke at hex and had to be replaced.(see event ce-06343-2023) currently, job 8831064 is new case.Patient reported the abutment is not secure it is rocking in site.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D4: device expiration date unknown / not provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie did not receive one (1) ldat4, bellatek® titanium abutment 4.1mm for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number (8831064-1).No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.A lot specific complaint history review is not conducted for psp complaints.Patient specific products have a unique one time use lot number.Therefore, a lot specific history search for this complaint is not performed.The customer did not submit images for the reported event.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.In the event that the product is not available, the abutment export milling file can be used for the comparison (image i).No discrepancies were observed.Based on the investigation and risk management file review as per rm-00057-haz rev.20/project 766 rev.05, the most likely root cause determined from the investigation was screw loosening due to insufficient torque.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: BELLATEK TITANIUM ABUTMENT 4.1MM
• 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 ; 5619713230
• MDR Report Key: 17406992
• Report Number: 0001038806-2023-01412
• Device Sequence Number: 7122040
• Product Code: NHA
• UDI-Device Identifier: 00844868031628
• UDI-Public: (01)00844868031628(10)8831064-1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052648
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2023

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: Lay User/Patient
• Device Catalogue Number: LDAT4
• Device Lot Number: 8831064-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic