FDA Adverse Event Injury Summary report: N

ADD (AKA VBR SMALL) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

MDR report key: 6553712 · Received May 7, 2017

Report

Report Number
MW5069619
Event Type
Injury
Date Received
May 7, 2017
Date of Event
October 1, 2016
Report Date
May 7, 2017
Manufacturer
ULRICH MEDICAL USA
Product Code
MQP
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

LITERATURE BRENKE, C, ET AL, "COMPLICATIONS ASSOCIATED WITH CERVICAL VERTEBRAL BODY REPLACEMENT WITH EXPANDABLE TITANIUM CAGES." JOURNAL OF CLINICAL NEUROSCIENCE 32 (2016): 35-40. "FOLLOWING THE INITIAL WAVE OF ENTHUSIASM, DIS-ADVANTAGES HAVE BEEN REPORTED. APART FROM THE HIGH COSTS, STATED BIOMECHANICAL DISADVANTAGES INCLUDE THE RISK OF OVER DISTRACTION, TILTING AND STRESS SHIELDING. FURTHERMORE, STUDIES HAVE SHOWN THAT ALTHOUGH EXPANDABLE VBR SYSTEMS CAN SERVE AS SOLID ANTERIOR COLUMN CONSTRUCTS, RESTORING, SAGITTAL HEIGHT AND ALIGNMENT, THE COMPLICATION AND RE-OPERATION RATES, ESPECIALLY IN TUMOR PTS, ARE HIGH." ANTERIOR CERVICAL CORPECTOMY WAS PERFORMED ON 50 CONSECUTIVE HUMAN SUBJECTS USING THE ADD VBR DEVICE (AKA VBR SMALL) BETWEEN OCTOBER 2010 AND MAY 2015; 22 (44%) CASES REQUIRED URGENT INTERVENTION; 23 (46%) PTS EXPERIENCED SUM TOTAL OF 42 COMPLICATIONS WITH 18 BEING DEVICE-RELATED. DISPLACEMENT OF THE VBR DEVICE ACCOUNTED FOR HALF OF THE DEVICE RELATED COMPLICATIONS. REVISION SURGERY WAS REQUIRED FOR 12 (24%) OF THE PT CASES AND ONE IN-HOSPITAL DEATH FROM NON-IDENTIFIED MEDICAL COMPLICATION. "HA (HARDWARE-ASSOCIATED) COMPLICATIONS SHOWED THAT COMPLICATIONS INVOLVING THE VBR (ADD), ESPECIALLY ITS DISPLACEMENT, OCCURRED IN 21% AND OUTNUMBERED PLATE/SCREW ASSOCIATED COMPLICATIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
332108 ADD (AKA VBR SMALL) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE ADD (AKA VBR SMALL) SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP ULRICH MEDICAL USA

Patients

Seq Age Sex Outcome Treatment
1 44 YR Hospitalization| R