PYRAMESH IMPLANT SYSTEM
Received Dec 3, 2014
Report 1030489-2014-04640 · MDR key 4295276
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED VIA A LITERATURE ARTICLE ENTITLED "VIDEO-ASSISTED TREATMENT OF THORACOLUMBAR JUNCTION FRACTURES USING A SPECIFIC DIS TRACTOR FOR REDUCTION: PROSPECTIVE STUDY OF 50 CASES" THAT THE CLINICAL AND RADIOLOGICAL RESULTS OF 50 PATIENTS OPERATED BETWEEN (B)(6) 2000 AND (B)(6) 2006 WITH A VIDEO-ASSISTED ANTERIOR APPROACH USING AN ENDODISTRACTOR FOR REDUCTION AND CONSEQUENT INSERTION OF THE IMPLANT WERE STUDIED. NINETEEN (19) WOMEN AND 31 MEN WERE TREATED; MEAN AGE WAS 43.3 YEARS OLD. IT WAS REPORTED THAT 4 PATIENTS SUFFERED NERVE DAMAGE, 1 PATIENT SUFFERED A LUNG INFECTION BUT HAD COMPLETE RECOVERY, AND 5 PATIENTS SUFFERED PULMONARY ATELECTASIA (THAT REGRESSED WITHIN 2 MONTHS). NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). 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.