VANTAGE ANTERIOR FIXATION SYSTEM

MDR report key: 3830835 · Received May 23, 2014

Report

Report Number: 1030489-2014-02625
Event Type: Injury
Date Received: May 23, 2014
Date of Event: April 22, 2014
Report Date: April 25, 2014
Manufacturer: WARSAW ORTHOPEDIC, INC.
Product Code: KWQ
PMA / PMN Number: K023797
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

X-RAY INTERPRETATION "L1 TO L3 CONSTRUCT AFTER L2 CORPECTOMY. LOOSE LOCKING NUT IS REPORTED AND WAS THE REASON FOR SURGICAL REVISION. X-RAYS SHOW AP VIEWS CENTERED ON L2 WITH AN L2 CORPECTOMY AND ANTERIOR CONSTRUCT WITH TWO SCREWS IN L1 AND TWO IN L3. THE CORPECTOMY DEVICE IS WELL POSITIONED AS ARE THE SCREWS AND STAPLES IMMEDIATELY POSTOP. SOMETIME LATER THE PLATE HAS LIFTED OFF THE L1 SCREW STAPLE ALLOWING THE CORPECTOMY DEVICE TO MIGRATE AND FOR SCOLIOSIS TO DEVELOP THROUGH THE CONSTRUCT."

Description of Event or Problem · 1

IT WAS REPORTED THAT AN ANTERIOR FIXATION PLATE SYSTEM WAS INITIALLY IMPLANTED IN A PATIENT DURING AN L2 CORPECTOMY AND L1-L3 ANTERIOR FIXATION PROCEDURE. IT WAS REPORTED THAT DURING A FOLLOW-UP X-RAY SEVEN DAYS POST-OP, THE LOCKING NUT WAS LOOSE. A REVISION SURGERY WAS PERFORMED 8 DAYS POST-OP. ACCORDING TO THE REPORT, "DURING THE REVISION SURGERY IT WAS DISCOVERED NOT ONLY WAS THE LOCKING NUT LOOSE, BUT IT WAS ALSO OFF OF STAPLE". NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
307900	VANTAGE ANTERIOR FIXATION SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	WARSAW ORTHOPEDIC, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	ANTERIOR FIXATION PLATE SYSTEM