FDA Adverse Event Injury Summary report: N

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

MDR report key: 17315296 · Received July 13, 2023

Report

Report Number: 0002023141-2023-01894
Event Type: Injury
Date Received: July 13, 2023
Date of Event: September 13, 2021
Report Date: July 12, 2023
Manufacturer: ZIMMER DENTAL
Product Code: DZE
UDI-DI: 00889024020054
PMA / PMN Number: K061410
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ZIMMER BIOMET COMPLAINT NUMBER (B)(4). E1: EMAIL ADDRESS UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K061410/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-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

DOCTOR OBSERVED THE BEGINNING OF PERI-IMPLANTITIS ON X-RAY'S CONTROL. AFTER 6 MONTHS, HE DECIDED TO REMOVE THE IMPLANT. #26.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2170409	IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM	DENTAL IMPLANT	DZE	ZIMMER DENTAL	TSVWB11	1230284	00889024020054

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR	Male