MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Fracture (1260)

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

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Fax number and last/given name unknown / not provided.Pma/510(k) number not available.

Event Description

It was reported that the implant internal screw at tooth site #14 was noted as fractured.Patient was numbed using lidocaine and implant was removed using trephine burs.

Event Description

No additional event information received at the time of this report.

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.D10: xiitp5410, osseotite® tapered certain® prevail® implant 5/4 x 10mm- lot# 2019080631.H6: tyoe of investigation codes were added: 4111.H6: investigation findings code was added: 3221.H6: investigation conclusions code was added: 4315.H10: narrative/data was updated.One unknown 3i screw and one osseotite® tapered certain® prevail® implant (b)(6) were reported for investigation.The implant was returned but it could not be confirmed whether or not the screw was returned since the implant drive feature was inaccessible.Visual evaluation of the as returned product identified bone residue around the external threads due to usage.Additionally, the internal drive feature was filled with debris thus could not be accessed/verified for screw fragment or damage.Functional testing could not be performed due to the nature of the devices and event.Pre-existing conditions noted on the per were diabetes & smoker.The reported devices had been placed on tooth #14 (universal) for approximately 1 year.X-ray or picture images were not provided.Per the applicable ifu, it is stated that improper technique and overloading may lead to device failure.Dhr and complaint history review could not be performed since the lot/item number was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, device malfunction and the reported event could not be verified since the implant drive feature was inaccessible and filled with debris.H3 other text : device inaccessible.

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11847726
• MDR Text Key: 251367287
• Report Number: 0001038806-2021-00857
• 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
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR