MAUDE Adverse Event Report: ZIMMER DENTAL; COVER SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported that when removing cover screw fractured and remains in a well seated implant and needs to be removed.Requesting screw removal tool #0493.Patient to return for fractured cover screw removal and placement of healing collar.As a result of this event, no injury to the patient was reported.Tooth location not reported.

Event Description

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

Manufacturer Narrative

One unknown legacy zimmer implant and cover screw were reported but not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use (ifu) and risk files.Functional testing could not be performed since the devices were not returned.No pre-existing conditions were noted on the per.The reported devices have been placed on an unknown tooth location for an unknown period of time.X-ray/picture images were provided.Appropriate documentation was reviewed.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.Based on the available information, device malfunction and the reported event could not be verified since the devices were not returned.The following sections have been updated: g6: checked "follow-up" h3: changed "yes" to "no".

• Type of Device: COVER SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11029030
• MDR Text Key: 222706710
• Report Number: 0002023141-2020-02320
• Device Sequence Number: 1
• Product Code: DZL
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention