VERTEX RECONSTRUCTION SYSTEM

Report

Report Number: 1030489-2018-01338
Event Type: Injury
Date Received: October 9, 2018
Date of Event: September 12, 2018
Report Date: October 9, 2018
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 7750348 AND 510K# K090714 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

PRE-OP DIAGNOSIS FOR INITIAL SURGERY: PROGRESSION OF DEFORMATION OF CERVICAL AND THORACIC VERTEBRA DUE TO "RA". TYPE OF PROCEDURE FOR INITIAL SURGERY: OC-T3 POSTERIOR FUSION IT WAS REPORTED THAT: ON (B)(6) 2018, AFTER REMOVING FULL-THREAD SCREW AND CABLE AT C1/2, POSTERIOR FUSION AT OC-T3 WAS PERFORMED. ON THE RIGHT SIDE WAS TITANIUM TAPER ROD, AND THE LEFT SIDE WAS ADJUSTABLE ROD AND 5.5 MM TITANIUM ROD. AXIAL DOMINO WAS USED FOR THE CONNECTION AT C4. ON (B)(6) 2018, POST-OP, IT WAS OBSERVED THAT FROM THE CAUDAL SIDE OF CONNECTION PART OF AXIAL DOMINO ON THE LEFT OF C4, THE 5.5MM TITANIUM ROD DEVIATED. MOREOVER, COMPRESSION FRACTURE OCCURRED AT T3 IN THE CAUDAL SIDE. RECONNECTION AND FUSION FOR EXTENDING SURGERY HAS BEEN PLANNED TO BE PERFORMED ON (B)(6) 2018.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
788407	VERTEX RECONSTRUCTION SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	0195931W

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention