FDA Adverse Event Malfunction Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 1834489 · Received September 10, 2010

Report

Report Number: 1030489-2010-01173
Event Type: Malfunction
Date Received: September 10, 2010
Date of Event: August 17, 2010
Report Date: August 17, 2010
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT #H10E0911, H10E0930, AND H10D7566. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 750020, 510K # K052187 WAS CLEARED IN THE UNITED STATES. THE MFR DATE FOR LOT H10E0911 IS 05/29/2010; THE MFR DATE FOR LOT H10E0930 IS 05/26/2010; THE MFR DATE FOR LOT H10D7566 IS 05/17/2010. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PT UNDERWENT A PLIF USING INTERBODY DEVICE AND POSTERIOR FIXATION AT L3-L5. DURING FINAL TIGHTENING OF THE SET SCREW, THREAD OF THE SET SCREW WAS DAMAGED SO THAT IT COULD NOT BE IMPLANTED. THE PEDICLE SCREW WAS ALSO REPLACED TO A NEW ONE AND THE NEW SET SCREW WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CD HORIZON SPINAL SYSTEM	SET SCREW	KWQ	MEDTRONIC SOFAMOR DANEK	NA	H10A1247

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR			IMPLANTED:\| PEDICLE SCEW\| CAGE: