MAUDE Adverse Event Report: BIOMET 3I UNKNOWN 3I SCREW; ABUTMENT SCREW

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  Injury  

Event Description

It was reported that the abutment screw had fractured requiring in the implant to be removed.Tooth #21.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Manufacturer Narrative

Upon review of the reported event, it was determined this event was previously reported under another complaint number (b)(4).Please disregard the submission of mfr.This event will continue to be reported under (b)(4) mdr decision tree # mdt631923.No further reports will be submitted for this complaint under (b)(4).Sections updated: b4: date of this report.G3: date complaint was found to have been duplicated and previously reported under (b)(4).G6: type of report and follow up number.H2: follow up type h10: manufacturer's narrative.

Event Description

There is no update to the previous complaint description provided.

• Brand Name: UNKNOWN 3I SCREW
• Type of Device: ABUTMENT SCREW
• 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: 13122094
• MDR Text Key: 283162411
• Report Number: 0001038806-2021-02437
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: No
• 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: BOPT5411 - 2019120424
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 82 KG