FDA Adverse Event Malfunction Summary report: N

KYPHX HV-R BONE CEMENT

MDR report key: 9568040 · Received January 9, 2020

Report

Report Number: 1030489-2020-00043
Event Type: Malfunction
Date Received: January 9, 2020
Date of Event: November 27, 2019
Report Date: January 22, 2020
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NDN
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT WAS NOT 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.

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #: CX01B, 510K #K102397 AND UDI #: (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT L4 & L5 DUE TO SPONDYLOLISTHESIS AND STENOSIS. INTRA-OP, INTRA-OP, THE EXTRAVASATION OF CEMENT TOOK PLACE AT LEVEL L4. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

DEVICE DEFICIENCY DESCRIPTION: NON- SYMPTOMATIC CEMENT EXTRAVASATION AT RIGHT SIDE OF LEVEL L4 DURING SURGERY. PRODUCT CAME INTO CONTACT WITH PATIENT AND WAS USED ACCORDINGLY TO IFU/LABELLING. - FENESTRATED SCREW CEMENT; IN-USE; - RIGHT SCREW - CEMENT VOLUME USED IN CC: 1.5 - NO ACTION TAKEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
35560	KYPHX HV-R BONE CEMENT	CEMENT, BONE, VERTEBROPLASTY	NDN	MEDTRONIC SOFAMOR DANEK USA, INC	NA	218510014

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR