MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301; ELEVATOR, SURGICAL, DENTAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the tip of the elevator fractured while removing tooth 16.The fractured tip was retrieved from the patient.No adverse events have been reported as a result of the malfunction.

Event Description

The clinician reports the implant was inserted (b)(6) 2020 in ada 7.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis, pain and increased sensitivity.No further patient complications were reported.

• Brand Name: ELEVATOR #301
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11313285
• MDR Text Key: 238621935
• Report Number: 0001032347-2021-00066
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036028176
• UDI-Public: (01)00841036028176(10)041211D11
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 09-0257
• Device Lot Number: 041211D11
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 22 YR