FDA Adverse Event Malfunction Summary report: N

CLARIANCE SAS

MDR report key: 16436209 · Received February 24, 2023

Report

Report Number: 3008992889-2022-00004
Event Type: Malfunction
Date Received: February 24, 2023
Date of Event: November 1, 2022
Report Date: February 23, 2023
Manufacturer: CLARIANCE SAS
Product Code: OVD
PMA / PMN Number: K172083
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

IT WAS REPORTED TO US THAT DURING IDYS-ALIF TIVAC SURGERY, UPON IMPACTION OF THE CAGE AND PLATE INTO THE DISC SPACE, TWO LOCKING RINGS SEPARATED FROM THE PLATE. THE TWO RINGS WERE RETRIEVED BY THE SURGEON. AS A CONSEQUENCE, 2 SCREWS WERE USED INSTEAD OF 4 TO SECURE THE PLATE. ORIGINALLY PLANNED IN THE PRE-OP STRATEGY, PEDICLE SCREWS WILL BE IMPLANTED. THIS EVENT IS REPORTABLE AS A MALFUNCTION.

Description of Event or Problem · 0

THE PLATE WAS ATTACHED TO THE ALIF CAGE AND PLACED ON THE INSERTER. UPON IMPACTION OF THE CAGE INTO THE DISC SPACE BOTH OF THE BOTTOM LOCKING RINGS ON THE PLATE BECAME LOOSE AND DISENGAGED FROM THE PLATE. THIS HAPPENED DURING THE PLACEMENT OF THE CAGE AND BEFORE THE SCREWS WERE INTRODUCED. ACCORDING TO THE SURGEON AND THE REPRESENTATIVE PRESENT DURING THE CASE, THERE WAS NOTHING OUT OF THE ORDINARY THAT TOOK PLACE AND NO EXCESSIVE FORCE WAS USED. THE SURGEON REMOVED THE LOOSE RINGS WITH PICK-UPS AND SECURED THE CAGE TO THE L5 VERTEBRAL BODY USING TWO SCREWS WITHOUT SECURING THE PLATE TO S1. THE TWO DISENGAGED RINGS WERE DISPOSED OF INTO THE SHARPS CONTAINER BEFORE THE REPRESENTATIVE COULD SECURE THEM TO BE SENT BACK FOR EVALUATION. NO INJURY TO THE PATIENT OR SIGNIFICANT DELAYS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
752632	CLARIANCE SAS	IDYS-ALIF CAGE 30X40 - H14MM - 14	OVD	CLARIANCE SAS	(01)0370078062651(17)251001(10)K7D9X-K726Y	K7D9X-K726Y

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown