MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Fracture (1260)

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

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (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.Device product code unknown / not provided.Catalog and lot number unknown / not provided.Udi not available.First/given name: unknown / not provided.Pma/510(k) number not available.

Event Description

It was reported fractured screw inside the implant.Screw was impossible to remove.Implant was explanted and a new implant was replaced.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative one unknown biomet screw were returned for investigation.Visual evaluation of the as returned implant identified damage to threads platform, likely due to implant removal.Fractured screw identified inside implant.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing could not be performed since the implant and screw were fractured.Pre-existing condition noted on the per was moderate bone density ¿ type ii.The reported device had been placed on tooth #unk (fdi) for approximately 4 years.Device history record (dhr), sterilization, and complaint history review could not be performed, as the subject lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.Therefore, based on the available information, device malfunction of the implant and screw did occur, and the reported event was confirmed.

Event Description

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

• 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: 15197491
• MDR Text Key: 297576029
• Report Number: 0001038806-2022-01231
• 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,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention