MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE 17° ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT

Model Number	ILPAC4330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Date of event unknown / not provided.
Event or Problem Description
It was reported that the multi-unit abutments on # 5 fractured.No information in the patients chart indicated implant fracture.Symptoms as a result of the event: pain & inflammation.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report d1: brand name d4: catalog number d9: device availability 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
One certain® low profile one-piece abutment 4.1mm(d) x 4mm(h) (ilpc444u) and one certain® low profile 17° abutment 3.4mm(d) x 2mm(h) (ilpac3217) were returned for investigation.Ilpc342u was also returned and evaluated without any malfunction, processed as an associated item and as such will not be investigated further.Visual evaluation of the as reported/returned products identified that they were fractured around the screw threads.Functional testing was not performed due to the nature of the devices and reported event.Pre-existing condition noted on the per was moderate bone density ¿ type ii.Tooth locations for all three returned devices were reported as #3, 5 & 7 (fdi).Placement period is 2 years.X-ray or picture images were not provided by the customer.Appropriate documentation was reviewed.Dhr review could not be performed since the lot numbers were not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the ilpc444u & ilpac3217 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events.Based on the available information, device malfunction did occur and the reported event was confirmed.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN® LOW PROFILE 17° ABUTMENT 3.4MM(D) X 2MM(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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12367657
• Report Number: 0001038806-2021-01596
• Device Sequence Number: 17247979
• Product Code: NHA
• UDI-Device Identifier: 00844868037613
• UDI-Public: (01)00844868037613(17)240308(10)2019030357
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/01/2022

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: 03/08/2024
• Device Model Number: ILPAC4330
• Device Catalogue Number: ILPAC3217
• Device Lot Number: 2019030357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 01/25/2022
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/24/2021; 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male