CD HORIZON SPINAL SYSTEM

MDR report key: 2871776 · Received December 13, 2012

Report

Report Number: 1030489-2012-02794
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: November 14, 2012
Report Date: November 14, 2012
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). HOSPITAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT WITH DEGENERATIVE DISEASE UNDERWENT A PROCEDURE AT L3-L5 VIA TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). AS THE SURGICAL INCISION WAS ABOUT TO BE CLOSED, A MISMATCH OF HEMOSTATIC-AGENT COUNTS CAUSED THE PHYSICIAN TO SEARCH IN THE PATIENT FOR THE MISSING HEMOSTATIC-AGENT. ACCORDING TO THE REPORT, THE HEMOSTATIC-AGENT WAS FOUND "TANGLED BETWEEN A ROD AND THE CROSSLINK WHICH WAS PLACED BETWEEN L4 AND L5". WHEN THE RIGHT SETSCREW OF THE CROSSLINK WAS LOOSENED TO RETRIEVE THE HEMOSTATIC-AGENT, THE SETSCREW HOLE BECAME STRIPPED BECAUSE THE PHYSICIAN EXERTED FORCE TO UNTIGHTEN THE SETSCREW. REPORTEDLY, THE LEFT SETSCREW OF THE CROSSLINK WAS REMOVED WITHOUT ANY PROBLEM BUT BECAUSE IT WAS IMPOSSIBLE TO REMOVE THE RIGHT SETSCREW, THE CROSSLINK AND THE RIGHT ROD HAD TO BE REMOVED. THE CONSTRUCT WAS REBUILT, AND THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. THE PROCEDURE TIME WAS DELAYED BY APPROXIMATELY 30 MIN, ACCORDING TO THE REPORT. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				CROSSLINK 4.75X10 MLTSPN 47-60MM, SET SCREW, ROD