UNKNOWN
Received Dec 19, 2011 · Event occurred Nov 15, 2011
Report 2031966-2011-00057 · MDR key 2393100
Device
Generic name
Pedicle Screw Spinal System
Manufacturer
Nuvasive, Inc.Model number
UNKNOWNCatalog number
NA
Lot number
UNKNOWN
Product problems
- Break
Patient
Not reported
- Failure of Implant
Narrative
Additional Manufacturer Narrative
(B)(4). NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE TO IDENTIFY THE BROKEN IMPLANT AND THE PRODUCT HAS NOT BEEN RETURNED TO NUVASIVE FOR ANALYSIS; NO ROOT CAUSE HAS BEEN IDENTIFIED. SHOULD THE COMPONENT BE RETURNED, INVESTIGATION WILL RESUME ANY RELEVANT INFORMATION WILL BE REPORTED. THE INTERVAL BETWEEN INITIAL AND REVISION SURGERIES SUGGEST A LACK OF SPINAL FUSION. LABELING REVIEW NOTES: "...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA AND VASCULAR OR VISCERAL INJURY."
Description of Event or Problem
A POLYAXIAL PEDICLE SCREW CONSTRUCT WAS REPORTED TO HAVE BEEN IMPLANTED IN (B)(6) 2009. REVISION SURGERY OCCURRED ON (B)(6) 2011 INVOLVING A SCREW BREAKAGE AT THE S1 VERTEBRAL BODY. DETAILS OF THE ORIGINAL CONSTRUCT, PATIENT DIAGNOSIS AND SPINE LEVELS, ETC. AS WELL AS PRODUCT EXPLANTED ARE NOT YET KNOWN. THE HOSPITAL HAS REPORTEDLY RETAINED THE EXPLANTED COMPONENTS.