MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Udi not available.Pma/510(k) number not available.

Event Description

It was reported that the screw fractured inside the implant when doctor was manually tightening the crown.The implant in tooth location 46 (fdi) was removed.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following sections 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 osseotite® tapered certain® implant 4 x 11.5mm (int411) and one unknown lb screw were returned for investigation.Visual evaluation of the as returned products identified a broken screw fragment inside the implant.Additionally, the implant¿s external threads, platform and collar were damaged from removal and there was bone residue around the external threads due to usage.Functional testing could not be performed due to the nature of the devices and event.Device history record (dhr) and complaint history review could not be performed as the lot/item number was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed for both devices as visual evaluation identified a broken screw fragment inside the implant.

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
• MDR Report Key: 11292270
• MDR Text Key: 230677849
• Report Number: 0001038806-2021-00225
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

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: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR