FDA Adverse Event Injury Summary report: N

IMP,TSV,MCOL MG,3.7MM,8MM

MDR report key: 21262429 · Received January 29, 2025

Report

Report Number: 0002023141-2025-00241
Event Type: Injury
Date Received: January 29, 2025
Date of Event: February 19, 2024
Report Date: January 29, 2025
Manufacturer: ZIMMER DENTAL
Product Code: DZE
UDI-DI: 00889024019768
PMA / PMN Number: K111889
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMVIE COMPLAINT NUMBER (B)(4). D10: CONCOMITANT MEDICAL PRODUCT: TSVMB8, IMP, TSV, MCOL MG, 3.7MM, 8MM, LOT: 1242437. 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.

Description of Event or Problem · 0

IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #25 - 26. BOTH IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: IMPLANT MOBILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1253418	IMP,TSV,MCOL MG,3.7MM,8MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		1242437	00889024019768

Patients

Seq	Age	Sex	Outcome	Treatment
1	31 YR	Female