FDA Adverse Event Malfunction Summary report: N

CEMENT, BONE, VERTEBROPLASTY

MDR report key: 5744259 · Received June 23, 2016

Report

Report Number: 1030489-2016-01869
Event Type: Malfunction
Date Received: June 23, 2016
Report Date: May 24, 2016
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: NDN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MEAN AGE: 44.8. PT SEX: 16 FEMALES, 36 MALE. LITERATURE CITATION: S.TEYSSEDOU, M. SAGET, L.E. GAYET, P.PRIES, C. BREQUE, T. VENDEUVRE "RADIOLOGIC STUDY OF DISC BEHAVIOR FOLLOWING COMPRESSION FRACTURE OF THE THORACOLUMBAR HINGE MANAGED BY KYPHOPLASTY: A 52-CASE SERIES". 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

A TOTAL OF 52 PATIENTS WHO UNDERWENT BALLOON KYPHOPLASTY WERE INCLUDED, WITH MEAN FOLLOW-UP OF 18.6 MONTHS, VK FELL FROM 13.9° PRE-OPERATIVELY TO 8.2°AT LAST FOLLOW-UP. DHI FOUND SIGNIFICANT SUPERIOR DISC SUBSIDENCE (P=0.0001) AND NON SIGNIFICANT INFERIOR DISC SUBSIDENCE (P=0.116). DA SHOWED SIGNIFICANTLY REDUCED SUPERIOR DISC LORDOSIS (P=4*10-5). SUPDHI CORRELATED WITH VK CORRECTION (R=0.32). PRE-OPERATIVE VK DID NOT CORRELATE WITH RADIOLOGICAL DEGENERATION OF THE ADJACENT DISC. THERE WERE 4 CASES OF CEMENT LEAKAGE IN THE SUPERIOR DISK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
400565		CEMENT, BONE, VERTEBROPLASTY	NDN	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR