FDA Adverse Event Injury Summary report: N

T3 PRO TAPERED IMPLANT 4/3MM (D) X 11.5MM (L)

MDR report key: 19509951 · Received June 11, 2024

Report

Report Number: 0001038806-2024-01218
Event Type: Injury
Date Received: June 11, 2024
Date of Event: March 27, 2024
Report Date: June 10, 2024
Manufacturer: BIOMET 3I
Product Code: DZE
UDI-DI: 00844868046721
PMA / PMN Number: K213672
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMVIE COMPLAINT (B)(4). A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS AND INFECTION 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 AND INFECTION HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCE'S 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. USED IMPLANT CONCIERGE STENT. TOOTH #5, 12 (UNIVERSAL).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1089870	T3 PRO TAPERED IMPLANT 4/3MM (D) X 11.5MM (L)	DENTAL IMPLANT	DZE	BIOMET 3I		2023030097	00844868046721

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR	Male	Required Intervention