MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL ABUTMENT

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Catalog# tsvwh10-impl tapered scr-v ha 4.7 mm 4.5mm 10mm; lot# 62754753 therapy date: (b)(6) 2021 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the abutment at tooth site #19 fractured.Failed attempts to remove the abutment/abutment screw resulted in implant removal.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: investigation type codes were added: 4111 h6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.H10: narrative/data was updated.One impl tapered scr-v ha 4.7 mm 4.5mm 10mm (tsvwh10) and one unknown zimmer abutment (only the hex) was returned for investigation.Visual inspection of the as returned product identified fractured implant collar which was not reported but identified during investigation, and additionally, fracture hex of abutment was found inside drive feature of implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing conditions noted on the per was none.However, the device was located on tooth site #19 (universal) for approximately 6 years 4 months.Dhr review was completed for the implant lot number 62754753.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.Dhr and complaint history review for unknown zimmer abutment could not be performed as the item/lot information was not available.Complaint history review was performed for the reported implant lot number (62754753) for similar events using keyword categories functional fracture and no other complaint was identified.July post market trending was reviewed and there were no actionable trends or corrective actions for the reported devices and events.Therefore, based on the available information, device malfunction has occurred and reported event was confirmed.

Event Description

Visual inspection of the as returned product identified fractured implant collar which was not reported but identified during investigation.Follow up with the customer revealed that they did not have any information in the patient's chart regarding the implant fracturing.

• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12009173
• MDR Text Key: 256497523
• Report Number: 0002023141-2021-01545
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT.; DENTAL IMPLANT.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR