FDA Adverse Event Injury Summary report: N

IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

MDR report key: 19372641 · Received May 22, 2024

Report

Report Number: 0002023141-2024-01691
Event Type: Injury
Date Received: May 22, 2024
Date of Event: April 7, 2024
Report Date: May 21, 2024
Manufacturer: ZIMMER DENTAL
Product Code: DZE
PMA / PMN Number: K061410
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K061410/K013227 . 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-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

DOCTOR REPORTED BONE LOSS AND INFECTION WITH SWELLING AT TOOTH SITE 12. PATIENT REFERRED DISCOMFORT AND PAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1451850	IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		61689647

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR	Female