FDA Adverse Event Injury Summary report: N

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

MDR report key: 15305333 · Received August 26, 2022

Report

Report Number: 0002023141-2022-02226
Event Type: Injury
Date Received: August 26, 2022
Date of Event: June 15, 2020
Report Date: August 26, 2022
Manufacturer: ZIMMER DENTAL
Product Code: DZE
PMA / PMN Number: K061410
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. UNIQUE IDENTIFIER (UDI) NUMBER NOT AVAILABLE. PREMARKET IDENTIFICATION K011028 AND K01322. 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 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PROCEDURE WAS COMPLETED WITH OTHER IMPLANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2356782	IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL		62095093

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR	Male	Required Intervention