FDA Adverse Event Injury Summary report: N

IMP,TSV,4.7,8,MTX,MG

MDR report key: 24957719 · Received April 22, 2026

Report

Report Number: 0001038806-2026-02202
Event Type: Injury
Date Received: April 22, 2026
Date of Event: December 22, 2025
Report Date: April 22, 2026
Manufacturer: ZIMVIE US CORP LLC
Product Code: DZE
UDI-DI: 00889024020030
PMA / PMN Number: K101977
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101977. 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS CAUSING A LOOSE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
275787	IMP,TSV,4.7,8,MTX,MG	DENTAL IMPLANT	DZE	ZIMVIE US CORP LLC		1219378	00889024020030

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR	Male	Required Intervention