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

Model Number	ILPC341U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that low profile abutment fractured at the screw of the abutment while taking measures.A portion remained inside the implant and implant was removed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One certain low profile one-piece abutment 3.4mm(d) x 1mm(h) (ilpc341u) and one 3i t3 non-platform switched tapered implant 3.25 x 13mm (bost3213) were returned for investigation.Visual evaluation of the as returned abutment identified fractured abutment screw at threads and inside implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing conditions noted on the per were high bone density - type i.The reported device had been placed on tooth 32 (fdi).Placed on a previously alloplastic site.Dhr review for the lot (2022070037) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2022070037) for similar events (complaint category keywords: fracture: screw) and no other complaint was identified.Therefore, based on the available information, device malfunction (fracture screw) did occur, and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H)
• Common Device Name: DENTAL ABUTMENT 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: 15535619
• Report Number: 0001038806-2022-01497
• Device Sequence Number: 12724756
• Product Code: DZE
• UDI-Device Identifier: 00844868021117
• UDI-Public: (01)00844868021117(17)270727(10)2022070037
• 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): 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ILPC341U
• Device Catalogue Number: ILPC341U
• Device Lot Number: 2022070037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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: BOST3213 LOT 2022030636
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female