MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that clinician they placed an unknown zimmer tsv 4.7 x 11.5 mm implant at tooth location unknown about 14 yrs ago.They do not have the item or lot # on file.About 4 years ago the screw loosened while the patient was out of town.Patient came into office and clinician removed & replaced the screw.Also did not have the original screw item number, but it was replaced with an mhlas.

Event Description

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

Manufacturer Narrative

An unknown zimmer screw and a unknown tsv 4.7 x 11.5 mm implant were not returned.Since products have not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.The customer did not claim any issues and no allegation of malfunction with unknown tsv implant.No further investigation will be conducted for the unknown tsv implant.No pre-existing conditions were noted on the per.The reported device location is unknown and was used for approximately 14 years ago.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.No complaint history review could be performed without relevant lot and item information.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.The following sections have been updated: g7: checked "follow-up." h3: changed "yes" to "no.".

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10770581
• MDR Text Key: 215916588
• Report Number: 0002023141-2020-01876
• 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
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention