KYPHX? HV-R? BONE CEMENT

Report

Report Number: 2953769-2010-00589
Event Type: Injury
Date Received: December 2, 2010
Date of Event: November 18, 2010
Report Date: November 18, 2010
Manufacturer: MEDTRONIC SPINE LLC
Product Code: NDN
PMA / PMN Number: K041584
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REPORT SOURCE: ABSTRACT TITLED "TRANSVENOUS CEMENT LEAKAGE INTO THE RIGHT ATRIUM AND CONSECUTIVE MYOCARDIAL INJURY DURING CEMENTAUGMENTED DORSAL SCREW-ROD FIXATION OF A TH12 FRACTURE", BY J. WALTER, A. WASCHKE, R. REICHART, R. KALFF, C. EWALD. METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

Description of Event or Problem · 1

IT WAS REPORTED IN AN ABSTRACT TITLED "TRANSVENOUS CEMENT LEAKAGE INTO THE RIGHT ATRIUM AND CONSECUTIVE MYOCARDIAL INJURY DURING CEMENT AUGMENTED DORSAL SCREW-ROD FIXATION OF A TH12 FRACTURE", THAT: A (B)(6) WOMAN WAS TREATED FOR A COMPLEX TH12 FRACTURE. THIS FRACTURE WAS ALREADY PRE-TREATED IN A DIFFERENT HOSPITAL WITH TRAN SPEDICULAR KYPHOPLASTY AND A DORSAL SCREW-ROD INSTRUMENTATION TH11 TO L1. DUE TO A SEVERE OSTEOPOROSIS, THERE WAS DISLOCATION OF THE INTERNAL OSTEOSYNTHESIS, WHICH MADE AN OPERATIVE REMOVAL OF THE COMPLETE SYSTEM NECESSARY. IN THE FOLLOWING COURSE, A FURTHER SINTERING OF THE AUGMENTED TH12 FRACTURE COULD BE SEEN, THAT LEAD TO A FRAGMENT DISLOCATION INTO THE SPINAL CANAL AND CONSECUTIVE COMPRESSION OF THE SPINAL CORD. FINALLY, WE SAW THE INDICATION FOR A DORSAL INSTRUMENTATION TH10/11 TO L1/2 WITH CEMENT AUGMENTED PEDICLE SCREWS AND LAMINECTOMY OF TH12 FOR DECOMPRESSION OF THE SPINAL CORD. THE PATIENT RECOVERED FROM THESE PROCEDURES COMPLETELY, WITHOUT ANY NEUROLOGICAL DEFICIT. NO FURTHER INFORMATION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KYPHX? HV-R? BONE CEMENT	BONE CEMENT	NDN	MEDTRONIC SPINE LLC	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	00062 YR		Required Intervention