MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H); DENTAL ABUTMENT

Catalog Number	ILPC341U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided, d4: additional device information: unknown / not provided, d10: concomitant medical product: ilpc441, certain¿ low profile abutment 4.1mm(d) x 1mm(h), lot: 2120019592, e1: reporter name: unknown / not provided, h4: device manufacturer date: unknown / not provided.
Event or Problem Description
Doctor reported screw fracture of two abutments despite of stressless fit and paying attention to torque.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability d10: concomitant medical product: ilpc341u, certain low profile one-piece abutment 3.4mm(d) x 1mm(h) lot number unknown.- updated.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) ilpc341u, (certain low profile one-piece abutment 3.4mm(d) x 1mm(h)) for evaluation.Visual evaluation was performed.Fracture screw identified at the top of abutment.The investigation refers to the ilpc341u device history record (dhr) review was completed for the subject lot number 2120024770.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 2120024770 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 was probably user caused therefore, based on the available information, a device malfunction has not occurred.Fracture screw identified at the top of abutment; however, the returned abutment was not fractured.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.

• Brand Name: CERTAIN¿ LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H)
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21783664
• Report Number: 0001038806-2025-00765
• Device Sequence Number: 8692358
• Product Code: NHA
• UDI-Device Identifier: 00844868021117
• UDI-Public: (01)00844868021117(17)291215(10)2120024770
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: ILPC341U
• Device Lot Number: 2120024770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/07/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT.; DENTAL ABUTMENT.
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic