MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)

Model Number	ILPC444U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that patient with upper and lower bars where the low profile abutment and retaining screws fractured.Tooth # 9 has a fractured abutment and retaining screw.Discovered upon removal of hybrid for routine maintenance.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Mfr report number 0001038806 - 2020 - 01767 , section "d4: device udi number" was submitted with (b)(4) in error.Associated lot # 2013041993 was manufactured prior to 24-sep-2015, as a result, a udi number is not required.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
A certain® low profile one-piece abutment 4.1mm(d) x 4mm(h) ilpc444u was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage.No pre-existing conditions were noted on the per.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number.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 was 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 for similar event and no other complaint was identified.Based on the available information, the event was unconfirmed for the abutment.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)
• Common Device Name: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10801642
• Report Number: 0001038806-2020-01767
• Device Sequence Number: 16873198
• Product Code: NHA
• UDI-Device Identifier: 00844868021049
• UDI-Public: (01)00844868021049(17)180705(10)2013041993(241)ILPC444U
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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: 07/05/2018
• Device Model Number: ILPC444U
• Device Catalogue Number: ILPC444U
• Device Lot Number: 2013041993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 02/15/2021; 02/24/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 02/18/2021; 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR