MAUDE Adverse Event Report: BIOMET 3I CERTAIN® GINGIHUE® POST 5MM(D) X 6MM(P) X 2MM(H); ABUTMENT

Model Number	IWPP562G
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant was removed due to peri-implantitis at the implant site.Customer reported implant had been placed in area #20.Abutment was inserted after 4 months of healing; after one week with provisional crown abute was noted to be loosed.Could not tighten abutment to implant to get platform to seat.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
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 reported device was returned for investigation.Visual evaluation of the returned product identified no damage and engaged inside in-house implant.Functional testing was done using an in-hose implant and was able to engage.No pre-existing conditions were noted on the product experience report (per).X-ray or picture images were not provided.Complainant reported that after one week with provisional crown abutment was noted to be loosed.Could not tighten abutment to implant to get platform to seat.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.A device history record (dhr)review was performed and no related deviations or nonconformance's were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.

• Brand Name: CERTAIN® GINGIHUE® POST 5MM(D) X 6MM(P) X 2MM(H)
• Common Device Name: 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: 15115078
• Report Number: 0001038806-2022-01141
• Device Sequence Number: 5849978
• Product Code: NHA
• UDI-Device Identifier: 00844868009030
• UDI-Public: (01)00844868009030(17)270314(10)1252904
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• 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
• Report Date (Section B): 01/10/2023

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 Model Number: IWPP562G
• Device Catalogue Number: IWPP562G
• Device Lot Number: 1252904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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
• Patient Age: 85 YR
• Patient Sex: Male