FDA Adverse Event Injury Summary report: N

IMP,TSV,MCOL MG,4.1MM,11.5MML

MDR report key: 16415020 · Received February 21, 2023

Report

Report Number: 0002023141-2023-00617
Event Type: Injury
Date Received: February 21, 2023
Date of Event: January 18, 2023
Report Date: February 21, 2023
Manufacturer: ZIMMER DENTAL
Product Code: DZE
PMA / PMN Number: K111889
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS 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 BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS 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 IMPLANT WAS PLACED VIA GUIDED SURGERY (IMPLANT CONCIERGE) AND GRAFTED 50 - 70% BONE LOSS, DISCOMFORT AT UNCOVERY APPOINTMENT. TOOTH # 30.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1644110	IMP,TSV,MCOL MG,4.1MM,11.5MML	DENTAL IMPLANT	DZE	ZIMMER DENTAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR	Male	Required Intervention