PYRAMESH IMPLANT SYSTEM
Received Apr 29, 2014
Report 1030489-2014-02347 · MDR key 3778178
Device
Product problems
- Migration or Expulsion of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED IN A PUBLICATION THAT A RETROSPECTIVE REVIEW OF A 12 MONTH PERIOD OF PATIENTS WHO HAD A CORPECTOMY PERFORMED. A TOTAL OF 91 PATIENTS UNDERWENT A CORPECTOMY WITH A 1 MONTH POSTOPERATIVE OF X-RAYS OR X-RAY IMAGING PERFORMED BY 2 SURGEONS. DATA WAS COLLECTED USING SURGERY AND CAGE RELATED PARAMETERS, SUCH AS SPINE REGION, SURGICAL LEVELS, SURGICAL APPROACH, GRAFT TYPE, CAGE TYPE, SUPPLEMENTAL INSTRUMENTATION, AND EXTENT OF POSTERIOR FUSION.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
LITERATURE ARTICLE CITATION: LAU ET AL. RADIOLOGICAL OUTCOMES OF STATIC VS EXPANDABLE TITANIUM CAGES AFTER CORPECTOMY: A RETROSPECTIVE COHORT ANALYSIS OF SUBSIDENCE, NEUROSURGERY. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.