FDA Adverse Event Injury Summary report: N

IMP,TSV,MCOL MG,4.7MM,11.5MML

MDR report key: 19365473 · Received May 21, 2024

Report

Report Number: 0002023141-2024-01683
Event Type: Injury
Date Received: May 21, 2024
Date of Event: January 9, 2024
Report Date: May 20, 2024
Manufacturer: ZIMMER DENTAL
Product Code: DZE
UDI-DI: 00889024019782
PMA / PMN Number: K111889
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMVIE COMPLAINT NUMBER (B)(4). AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K111889/K101880. . A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. SUMMARY INVESTIGATION.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE IMPLANTS AT TOOTH #15/16 WERE REMOVED DUE TO PERI-IMPLANTITIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1565865	IMP,TSV,MCOL MG,4.7MM,11.5MML	DENTAL IMPLANT	DZE	ZIMMER DENTAL		63308210	00889024019782

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female