MAUDE Adverse Event Report: BIOMET 3I UNK UCLA SCREW; ABUTMENT SCREW

Catalog Number UNK UCLA SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2018

Event Type  malfunction  

Event Description

It was reported that the full cast crowns came loose and were retorqued to the implants on (b)(6) 2018.

Manufacturer Narrative

Zimmerbiomet (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog, lot number, expiration date, and unique identifier (udi) number unknown / not provided.Pma/510(k) number not available.Device manufacturer date.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The reported device was not returned for investigation.Since products have not been returned, visual/functional inspection could not be performed.No pre-existing conditions were noted on the product experience report (per).The customer did not provide any pictures or x-rays.The reported device was located on tooth sites # 18 and was used for approximately 2 years, and 11 months.A device history record (dhr) review and complaint history review could not be performed, as the lot numbers associated with the reported product are not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complainant reported that the full cast crowns came loose and were retorqued to the implants.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.The following sections have been updated: h3: device evaluated by manufacturer; h6: evaluation codes; h10: additional narrative h3 other text : item not returned to manufacturer.

• Brand Name: UNK UCLA 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: 13067708
• MDR Text Key: 284008908
• Report Number: 0001038806-2021-02414
• 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: 06/22/2022

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: Lay User/Patient
• Device Catalogue Number: UNK UCLA SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male