KYPHX® HV-R¿ BONE CEMENT

Report

Report Number: 1030489-2013-01680
Event Type: Injury
Date Received: May 13, 2013
Date of Event: April 14, 2013
Report Date: April 14, 2013
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: NDN
PMA / PMN Number: K093828
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AT L3 TO TREAT PSEUDOARTHROSIS DUE TO COMPRESSION FRACTURE WITHOUT POSTERIOR WALL INJURY. IT WAS REPORTED THAT CEMENT EXTRAVASATION "TO THE INTRADISCAL OCCURRED" INTRA-OPERATIVELY AND THE PHYSICIAN "STOPPED THE INJECTION OF THE CEMENT AND WAITED UNTIL THE HARDENING OF THE CEMENT." THE FINAL X-RAY TAKEN INTRA-OPERATIVELY "CONFIRMED THAT THE CEMENT REMAINED IN THE MUSCLE AND THE CEMENT WAS REMOVED IMMEDIATELY." PER THE PHYSICIAN, "IT WAS NOT AWARE THAT INFERIOR ENDPLATE BROKE DUE TO POOR BONE QUALITY WHEN THE BALLOON WAS INFLATED, AND THE CEMENT LEAKAGE OCCURRED. ALSO, THE REMAINING AMOUNT OF THE CEMENT IN THE BONE FILLER DEVICE (BFD) WAS NOT CHECKED, AND THE PLUNGER OF THE BFD WAS PUSHED. AS THE RESULT, THE CEMENT REMAINED IN THE MUSCLE. THE PHYSICIAN COMMENTED THAT THE EVENT WAS CAUSED BY CARELESSNESS." IT WAS ALSO REPORTED THAT "THE CEMENT VISCOSITY WAS GOOD." THE CEMENT WAS SUCCESSFULLY REMOVED FROM THE MUSCLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
211142	KYPHX® HV-R¿ BONE CEMENT	CEMENT, BONE, VERTEBROPLASTY	NDN	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				BKP