FDA Adverse Event Injury Summary report: N

NEXIS

MDR report key: 18455928 · Received January 5, 2024

Report

Report Number: 3010673777-2023-00003
Event Type: Injury
Date Received: January 5, 2024
Date of Event: November 16, 2023
Report Date: December 28, 2023
Manufacturer: NOVASTEP SAS
Product Code: HWC
PMA / PMN Number: K143146
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

FIRST OCCURRENCE OF SUCH AN ADVERSE EVENT RELATIVE TO NOVASTEP PRODUCTS. DEVICE UNAVAILABLE AS THE PATIENT REQUIRED TO KEEP IT ONCE REMOVED.

Description of Event or Problem · 0

WE HAVVE BEEN INFORMED BY OUR DISTRIBTOR THAT ONE OF OUR REMOVAL SCREWDRIVER WAS REQUIRED IN ORDER TO REMOVE A SNAP-OFF SCREW FROM A PATIENT. ACCORDING TO THE SALES REPRESENTATIVE, THE REASON FOR REMOVAL WAS SCAR TISSUE / PATIENT PAIN AND TIGHTNESS. HOWEVER, DESPITE SEVERAL REMINDERS FROM OUR DISTRIBUTOR WHO HIMSELF CONTACTED HIS CUSTOMER, IT WAS NOT POSSIBLE TO RETRIEVE THE FOLLOWING INFORMATION (REFERENCE OF THE IMPLANT, BATCH NUMBER, DATE OF IMPLANTATION,...). IT WAS NOT POSSIBLE ALSO TO COLLECTE INFORMATION ABOUT THE DESCRPTION OF THE EVENT (NO X-RAY, NO ANALYSIS OF THE EXPLANTED IMPLANT GIVEN THAT IT WILL NOT BE RETURNED).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
908085	NEXIS	SNAP-OFF SCREW	HWC	NOVASTEP SAS		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other