n NASS News | Safety Notices
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Spine Safety Notices
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s Med Watch
Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 at: www.fda.gov/medwatch/getforms.htm. Mail to address
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DRUG/DEVICE/OTHER NOTIFICATION TYPE FULL REPORT:
Sterile Drug Products | Vital Rx, dba Atlantic Pharmacy &
Recall: Lack of Sterility Assurance https://goo.gl/VTUiGA
Vancomycin Hydrochloride for Injection, USP, 750mg/vial |
Recall: Presence of Particulate Matter https://goo.gl/1dbcCJ
Cyclobenzaprine HCI and Amantadine HCI | Apace Packaging Recall: Potential Mislabeling https://goo.gl/F6cgUJ
Sterile Drug Products | Cantrell Drug Company Recall: Lack of Sterility Assurance https://goo.gl/LzSNJz
Sterile Drug Products | Bella Pharmaceuticals Recall: Lack of Sterility Assurance https://goo.gl/8JQTA4
Alert Warning Cautionary Notice
(High Impact) (Moderate impact) (Low Impact)
On July 28, 2017, the NASS Board of
The complaint against Dr. Gertzbein
Directors voted to approve the recom-
mendation of the Professional Con-
duct and Ethics Committee (PCEC)
that Dr. Stanley Gertzbein be censured
for violating the following portion of
NASS' Expert Witness Guidelines:
A NASS member serving as an
expert should be engaged in the
active practice of medicine or,
alternatively, should be able to
demonstrate sufficient familiarity
with present practices in the area
of his or her testimony to warrant
designation as an expert witness.
was initiated by Dr. Leon Liem who
alleged, in pertinent part, that Dr.
Gertzbein misrepresented the stan-
dard of care when discussing the tech-
nique that should be used to prevent
cage migration in a PLIF procedure.
Specifically, Dr. Liem challenged Dr.
Gertzbein’s testimony recommending
that the posterior lip be retained.
Dr. Gertzbein, in response, argued
that while he advocated for retaining
the posterior lip, he did not mean to
imply that this was a mandatory part
of the technique. Rather, Dr. Gertzbein represented that it was his intent
to suggest that this was one of several
factors that could be used to prevent
The PCEC held a hearing on this
issue alone at the 2016 Annual Meeting in Boston, MA, as other provisions
of Dr. Liem's complaint were previously dismissed. Upon reviewing the
evidence presented at the hearing,
the PCEC interpreted Dr. Gertzbein’s
testimony to advocate that retaining
the posterior lip was part of the standard of care in a PLIF, and that this
recommendation was not in line with
In addition, Dr. Gertzbein had, admittedly, not performed the procedure
in question, and the Commitee found
he did not have strong support for his
position in the literature. In light of
these factors the PCEC recommended
the sanction of public censure.
Notice of Public Censure