MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE 30 ABUTMENT 3.4MM(D) X 3MM(H); DENTAL SCREW

Catalog Number	ILPAC3330
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that the multi-unit has slight mobility, the screw does not tighten or loosen, the wrench turns but the screw threads are worn, only managed to disassemble by wearing down the screw with a drill.Affected dental position: 12; bone type: unknown.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) ilpac3330, (certain® low profile 30° angled abutment 3.4mm(d) x 3mm(h)) for evaluation.Visual evaluation was performed.Signs of use was identified.The abutment¿s retaining screw was not returned with the abutment.Unable to functionally test the device.Unable to confirm loosening with all the available information.A placement tool was returned attached to the abutment.No failures were identified dhr review was completed for the subject lot number 2021080233.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2021080233 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : loosening.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was abutment screw is not torqued to specification therefore, based on the available information, a device malfunction could not be verified.The abutment¿s retaining screw was not returned with the abutment.Unable to functionally test the device.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 product was 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN LOW PROFILE 30 ABUTMENT 3.4MM(D) X 3MM(H)
• Common Device Name: DENTAL SCREW
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18973671
• Report Number: 0001038806-2024-00561
• Device Sequence Number: 6693956
• Product Code: NHA
• UDI-Device Identifier: 00844868037590
• UDI-Public: (01)00844868037590(17)260910(10)2021080233
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K092341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 09/09/2026
• Device Catalogue Number: ILPAC3330
• Device Lot Number: 2021080233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• 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: 03/25/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic