MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Catalog, lot, udi number unknown / not provided.Email address unknown / not provided.Pma/510(k) number not available.One unknown legacy biomet screw was returned for investigation.The investigation was conducted on the implants and screw.Visual evaluation of the as returned product identified screw fragment in one of the implants drive feature.Functional testing was not performed since the devices were fractured.Pre-existing condition noted on the per is moderate bone density type ii.The reported devices had been placed on tooth # thirty six & thirty seven (fdi) for approximately seven and a half years.X-ray and picture images were not provided.Documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev g - october 2019 / biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: warnings and precautions (page 3).Per the applicable ifu, breakage may occur when device is loaded beyond its functional capability.All products were conforming at the time they left zimmer biomet.November post market trending was reviewed and there were no actionable trends or corrective actions for the reported devices and events.Therefore, based on the available information, device malfunction did occur and the reported events were confirmed.

Event Description

Doctor reported two implant fractured and were removed.Upon investigation results, it was identified a fractured screw inside one of the implants.

• Type of Device: DENTAL 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: 11154677
• MDR Text Key: 228673895
• Report Number: 0001038806-2021-00064
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR