MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT

Catalog Number ILPC342U

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).D10: concomitant medical product and therapy dates: ilpcc342u,certain low profile one-piece abutment 3.4mm(d) x 3mm(h).

Event Description

The doctor reports that the abutments located in positions #31 and #42 failed because they do not fit properly, do not tighten correctly, and are not stable.The doctor also reports that the dental procedure was completed with the placement of new abutments.The health of the patient was not affected.Received only one (1) of the reported ilpc342u.Additionally, received one (1) ilpc343u that was not reported the abutment was fractured at the threads.The complaints coordinator called and confirmed that both abutments screw were fractured.The item will be modified to the new reference, and the new fracture-abutment category was added.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d3: manufacturer email address d4: additional device information d9: device availability g1: contact office (and manufacturing site for devices) contact name and email g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative zimvie received one (1) ilpc342u, (certain low profile one-piece abutment 3.4mm(d) x 2mm(h)) for evaluation (images are attached in the complaint).Visual evaluation was performed, a fracture has been identified at the threads.Dhr review was completed for the subject lot number 2023040316.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 2023040316 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : screw based on the investigation and risk management file review, the most likely root cause determined from the investigation were missing or confusing instructions for use and clinician incorrectly engages abutment screw into implant.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the threads.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: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H)
• Type of Device: 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18535962
• MDR Text Key: 333149059
• Report Number: 0001038806-2024-00083
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K092341
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ILPC342U
• Device Lot Number: 2022080797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL ABUTMENT
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic