MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H); DENTAL ABUTMENT

Catalog Number	ILPC442U
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).D10.T3pt6510, t3 pro tapered implant 6/5mm (d) x 10mm (l) / unknown lot #; d10.Lpchc, low profile abutment healing cap / 2023010582; e1: reporter email address unknown / not provided.It is unknown if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported an implant was placed, then a diem mua was placed with a healing cap to suture.When finishing suturing, the doctor went to take off the healing cap to place an impression coping and the entire abutment came unscrewed with the heal cap attached at tooth site #19.The implant did not come out, to place the healing cap the doctor used the thumb driver to place the healing cap.When the doctor seated the abutment, the 3i prosthetic kit (npsdko)to torque the abutment in at 10 ncm.The doctor was able to complete the procedure by placing a new 3i straight mua.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report; b5: describe event or problem; d1: brand name updated; d9: device availability; g3: date received by manufacturer; g6: type of report; h1: type of reportable event; h2: follow up type; h3: device evaluated by manufacturer; h10: additional narrative.Zimvie did not receive one (1) ilpc442u, (certain¿ low profile one-piece abutment 4.1mm(d) x 2mm(h)) 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 2022120370.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 2022120370 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : disengaged.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00057-haz, the most likely root cause determined from the investigation was the torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction was not established.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 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: 18773480
• Report Number: 0001038806-2024-00301
• Device Sequence Number: 4462405
• Product Code: NHA
• UDI-Device Identifier: 00844868021063
• UDI-Public: (01)00844868021063(17)280113(10)2022120370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092341
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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 Catalogue Number: ILPC442U
• Device Lot Number: 2022120370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANT T3PT6510 AND HEALING CAP LPCHC.; IMPLANT T3PT6510 AND HEALING CAP LPCHC.
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic