MAUDE Adverse Event Report: ZIMMER DENTAL UNKNOWN ZIMMER SCREW

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Patient information not provided/unknown.Event date not provided/unknown.Device brand name unknown.Device product code unknown.Device catalog number and lot number not provided/unknown.Device not returned.

Event Description

It was reported that the unknown zimmer screw loosened.

Event Description

It was reported that the unknown zimmer screw loosened at tooth location 18, was retorqued and a new screw was placed.There was no report of patient injury.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: b5: it was reported that the unknown zimmer screw loosened at tooth location 18, was retorqued and a new screw was placed.There was no report of patient injury.Concomitant medical products: unknown zimmer screw.Pma/510k: 24 june 2019 the reported device was not returned for evaluation.The reported condition of a screw that loosened was not confirmed.A device history record (dhr) review and complaint history review for the reported device could not be performed as the device item and lot number are unknown.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN ZIMMER SCREW
• Type of Device: SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8558253
• MDR Text Key: 143594913
• Report Number: 0002023141-2019-00182
• Device Sequence Number: 1
• Product Code: HWC
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1