FDA Adverse Event Injury Summary report: N

IMPL TWIST MP-1 5.0 MM 10 MM

MDR report key: 13695270 · Received March 8, 2022

Report

Report Number: 0002023141-2022-00605
Event Type: Injury
Date Received: March 8, 2022
Date of Event: July 26, 2021
Report Date: March 8, 2022
Manufacturer: ZIMMER DENTAL
Product Code: DZE
PMA / PMN Number: K013494
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510(K) NUMBER IS K962106. 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 THAT THE IMPLANT AT TOOTH SITE # 19 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. THE SITE WAS GRAFTED AND A NEW IMPLANT WAS PLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
936750	IMPL TWIST MP-1 5.0 MM 10 MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		991673

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR	Female	Required Intervention