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

Model Number	ILPC342U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient had crown mobility.Abutments were observed to be fractured at the screw of the abutment and were removed.Procedure was completed with new low profile abutments.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).Patient identifier: unknown / not provided.Weight: unknown / not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.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.Two certain low profile one-piece abutment 3.4mm(d) x 2mm(h) (ilpc342u) were returned for investigation.Visual evaluation of the as returned abutment identified signs of wear.Both abutments were fractured at the threads.A fractured screw identified in one of the abutments.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.No pre-existing conditions were noted on the per.Tooth 44 and 46.Device history record (dhr) review was completed for the subject lot number (2018050962).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2018050962) for similar events and no other complaint was identified.(complaint category keyword(s): fractured screw).Therefore, based on the available information, device malfunction (fracture screw) did occur, and the reported event was confirmed.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15549426
• Report Number: 0001038806-2022-01518
• Device Sequence Number: 13942606
• Product Code: DZE
• UDI-Device Identifier: 00844868021100
• UDI-Public: (01)00844868021100(17)230521(10)2018050962
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K092341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Expiration Date: 05/21/2023
• Device Model Number: ILPC342U
• Device Catalogue Number: ILPC342U
• Device Lot Number: 2018050962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2018
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ILPC342U LOT 2018050962
• Patient Age: 75 YR
• Patient Sex: Male