MAUDE Adverse Event Report: BIOMET 3I LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	LPC442
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the patient had the crown with mobility and when trying to remove the retaining screw, it did not come out and the screw remained embedded in the low profile abutment.The doctor cannot remove it and has to use pliers, which causes the screw threads to damage.The doctor confirmed that the procedure was concluded with another instruments and that the patient did not suffer any impact on his health.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-(b)(4).One low profile abutment (lpc442) was returned for investigation.Visual evaluation of the as returned abutment identified that the abutment screw threads were damaged.Functional testing was performed to disengage the abutment screw from the base ¿ they were able to disengage as normal.Pre-existing condition noted on the complaint was 'low bone density ¿ type iii'.The devices were intended for tooth 15 (universal).Device history record review for the lot (2020070259) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.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 (2020070259) for similar events (complaint category keywords: loosening & does not disengage) and no other complaint was identified.July post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information, abutment malfunction did occur but unknown screw malfunction and the reported events could not be verified as the exact details of event were unknown/nonverifiable.

• Brand Name: LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12313069
• Report Number: 0001038806-2021-01507
• Device Sequence Number: 4301675
• Product Code: NHA
• UDI-Device Identifier: 00844868021339
• UDI-Public: (01)00844868021339(17)250723(10)2020070259
• 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): 09/29/2021

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: Health Professional
• Device Expiration Date: 07/23/2025
• Device Model Number: LPC442
• Device Catalogue Number: LPC442
• Device Lot Number: 2020070259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR