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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW
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BIOMET 3I; DENTAL SCREW Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2020
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One unknown biomet implant and one unknown biomet screw were returned for investigation.Visual evaluation of the as returned products identified screw fragment in the implant drive feature, platform/collar was fractured and external threads were damaged.Additionally, there was bone residue around the external threads due to usage.Functional testing and dimensional analysis could not be performed since the devices were fractured.Pre-existing condition noted on the per was 'bruxism'.The reported device had been placed on tooth 36 (fdi) for approximately 12 years.Picture and x-ray images were not provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev g - (b)(6) 2019 & biomet 3i restorative products ifu (p-iis086gr) rev f - (b)(6) 2019.Per the applicable ifu, it is stated that breakage may occur when device is loaded beyond its functional capability.Also, according to the ifu, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.Device history record (dhr) review could not be performed since the lot number was unknown.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Complaint history review could not be performed as the lot/item number was unknown.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, implant malfunction (fracture) and an unreported screw malfunction (screw fracture) did occur.
 
Event Description
It was identified during investigation a fracture screw.
 
Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One unknown biomet implant and one unknown biomet screw were returned for investigation.Visual evaluation of the as returned products identified screw fragment in the implant drive feature, platform/collar was fractured and external threads were damaged.Additionally, there was bone residue around the external threads due to usage.Functional testing and dimensional analysis could not be performed since the devices were fractured.Device history record (dhr) review could not be performed since the lot number was unknown.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Complaint history review could not be performed as the lot/item number was unknown.Therefore, based on the available information, implant malfunction (fracture) and an unreported screw malfunction (screw fracture) did occur.Additionally, the reported event (implant fracture) was confirmed.
 
Event Description
No further event information is available at the time of this report.
 
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Type of Device
DENTAL SCREW
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key11420220
MDR Text Key240423195
Report Number0001038806-2021-00374
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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