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

Device Problem Unintended Movement (3026)

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

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier unknown / not provided age and date of birth unknown / not provided patient sex unknown / not provided weight unknown / not provided brand name unknown / not provided catalog and lot number unknown / not provided concomitant medical devices: bost510- 3i t3® non-platform switched tapered implant 5 x 10mm, lot# 2018101779.Pma/510(k) number not available 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 screw came loose and could not be retightened.It would keep spinning, which is why the implant was removed.No visible malfunctions or damage to the implant.The patient wanted to start over.

Manufacturer Narrative

This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: type of investigation codes were added: 4111 and 4114.H6: investigation findings code was added: 3221.H6: investigation conclusions code was added: 4315.One unknown biomet screw was reported but not returned for investigation.Visual evaluation of the as returned products identified bone residue around the implant¿s threads due to usage.Pre-existing condition noted was moderate bone density - type ii.The products were intended for tooth #13.Per the applicable ifu, reuse of biomet 3i products that are labeled for single-use may result in product contamination, patient infection and/or failure of the device to perform as intended.Dhr could not be reviewed for the unknown biomet screw.However, complaint history could not be reviewed for the unknown biomet screw.Therefore, screw malfunction and the reported event could not be verified since the device was not returned and as the exact details of event were non-verifiable.H3 other text : device expected but not returned.

Event Description

No additional event information at the time of this report.

• Type of Device: DENTAL 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: 12143710
• MDR Text Key: 260802126
• Report Number: 0001038806-2021-01205
• 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,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT-SEE H10 NARRATIVE; DENTAL IMPLANT
• Patient Outcome(s): Required Intervention