MAUDE Adverse Event Report: BIOMET 3I CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 2MM(H)

Model Number IMHA32

Device Problem Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2022

Event Type  Injury  

Event Description

It was reported that the abutment became stuck on the implant resulting in implant removal.Tooth #19.

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Patient weight not provided.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

One (1) certainâ® epâ® healing abutment 3.4mm(d) x 3.8mm(p) x 2mm(h) (imha32) & one (1) osseotite tapered certain implant 3.25 x 8.5mm (xifnt3285) were returned for investigation.Visual evaluation of the as returned product identified the abutment does not disengage from the implant.Malfunction.Functional testing to recreate the reported event verified the abutment is stuck to the implant and does not disengage/release.A pre-existing condition noted on the per was unknown bone density type.The reported devices were located on tooth # 19 (universal) and were used for approximately 5 months, 9 days.The customer did not provide any pictures or x-rays.Review of appropriate documentation: document reviewed: biomet 3i restorative products ifu (p-zbdinstrp), rev e 2022/04/01.Biomet 3i dental implant ifu (p-iis086gi) rev j - 2022/08/01.Information identified: warnings and precautions.Per the applicable ifu, breakage/device failure may occur following improper techniques used and when device is loaded beyond its functional capability.Dhr review: dhr review was completed for the subject lot numbers (1246684).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, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot numbers (1246684) for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release post market trending review: aug post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (imha32).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, devices malfunction did occur and the reported event was confirmed.

• Brand Name: CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 2MM(H)
• Type of Device: 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: 14224800
• MDR Text Key: 290259660
• Report Number: 0001038806-2022-00585
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868006251
• UDI-Public: (01)00844868006251(17)260806(10)1246684
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IMHA32
• Device Catalogue Number: IMHA32
• Device Lot Number: 1246684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: XIFNT3285 2021010521
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female