FDA Adverse Event Injury Summary report: N

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

MDR report key: 16830415 · Received April 28, 2023

Report

Report Number: 0002023141-2023-01192
Event Type: Injury
Date Received: April 28, 2023
Date of Event: January 31, 2023
Report Date: April 28, 2023
Manufacturer: ZIMMER DENTAL
Product Code: DZE
UDI-DI: 00889024019522
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). PMA/510(K) NUMBER :K01102 AND K013227. 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-CONFORMITIES 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

DOCTOR REPORTED PERI-IMPLANTITIS WITH DISCOMFORT AND PAIN AT TOOTH LOCATION 13.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
476187	IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL	TSVB13	1251488	00889024019522

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR	Male	Required Intervention