FDA Adverse Event Malfunction Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 2177708 · Received July 26, 2011

Report

Report Number: 1030489-2011-00940
Event Type: Malfunction
Date Received: July 26, 2011
Date of Event: June 22, 2011
Report Date: June 22, 2011
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWP
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT # H11D1114, EXPIRATION DATE 05/02/2019; LOT #H10D2274, EXPIRATION DATE 05/10/2019. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7540020, 510K # K052187 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H11D1114 IS 11/16/2009; THE MANUFACTURE DATE FOR LOT H11D2274 IS 04/19/2011. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS 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 PATIENT UNDERWENT A PROCEDURE VIA PLIF USING INTERBODY DEVICE AND POSTERIOR FIXATION. DURING FINAL TIGHTENING FOR THE BREAK OFF SET SCREW, THE DRIVER SLIPPED AND THE SET SCREW COULD NOT BE BROKEN OFF. THE SET SCREW WAS REPLACED AND FOUND WAS CROSS-THREADED. THE REPLACED SET SCREW WORKED WELL AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO PATIENT INJURY WAS 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		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00073 YR			PEDICLE SCREW