UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH

Additional Manufacturer Narrative

THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ROBINSON Y.,(2008), SUCCESSFUL TREATMENT OF SPONDYLODISCITIS USING TITANIUM CAGES: A 3-YEAR FOLLOW-UP OF 22 CONSECUTIVE PATIENTS, ACTA ORTHOPAEDICA, VOLUME 79 (5), PAGES 660-664 (GERMANY). THIS RETROSPECTIVE STUDY AIMS TO INVESTIGATE THE EFFECT OF THE USE OF METAL IMPLANTS ON THE CLINICAL AND RADIOLOGICAL OUTCOMES IN 22 CONSECUTIVE PATIENTS WITH SPONDYLODISCITIS. DURING A PERIOD OF 3 YEARS (MARCH 2003 TO JANUARY 2005), A TOTAL OF), 34 PATIENTS WITH ACUTE SINGLE OR MULTILEVEL SPONDYLODISCITIS (22 LUMBAR, 17 THORACIC, AND 4 CERVICAL DISCS) WERE TREATED SURGICALLY. 22 OF THESE PATIENTS (MEAN AGE 69 (43¿82) YEARS, 15 MEN) WITH 20 INFECTED LUMBAR AND 12 INFECTED THORACIC DISCS RECEIVED AN ANTERIOR TITANIUM CAGE IMPLANTATION (HARMS-MESH OR X-TENZ; BOTH FROM DEPUY SPINE, CITY, UK). 19 PATIENTS WERE OPERATED WITH A CIRCUMFERENTIAL PROCEDURE INCLUDING TITANIUM SCREW ROD INSTRUMENTATION (MOSS MAX OR MOSS MIAMI; DEPUY SPINE) AND 3 PATIENTS WERE OPERATED WITH AN ANTERIOR-ONLY PROCEDURE WITH ANTERIOR TITANIUM INSTRUMENTATION. RADIOGRAPHIC (LATERAL AND AP) AND CLINICAL (C-REACTIVE PROTEIN, WHITE BLOOD CELL COUNT) FOLLOW-UP DATES WERE 6 WEEKS, 12 WEEKS, 6 MONTHS, AND 1 AND 3 YEARS POSTOPERATIVELY. THE MEAN FOLLOW-UP TIME WAS 36 (32¿47) MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE PATIENT SUFFERED A LETHAL CARDIAC FAILURE 2 WEEKS AFTER THE STAGED ANTERIOR PROCEDURE. AT THE FINAL FOLLOW-UP, MEAN 36 MONTHS AFTER THE OPERATION, THERE WAS A MEAN SEGMENTAL LOSS OF CORRECTION OF 3.7 (0¿6) DEGREES COMPARED TO EARLY POSTOPERATIVE RADIOGRAPHS (FIGURES 1 AND 2). MICROBIOLOGICAL ANALYSIS OF SPECIMENS OBTAINED DURING THE SURGICAL DEBRIDEMENT IDENTIFIED THE PATHOGEN IN 13 CASES: STAPHYLOCOCCUS AUREUS 7 CASES, COAGULASE-NEGATIVE STAPHYLOCOCCI 2 CASES, ESCHERICHIA COLI 2 CASES, PROTEUS MIRABILIS 1 CASE, MYCOBACTERIUM TUBERCULOSIS 1 CASE. ONE PATIENT DIED BECAUSE OF CARDIAC ARREST 6 MONTHS AFTER THE OPERATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES HARMS-MESH , X-TENZ, MOSS MAX AND MOSS MIAMI. THIS IS REPORT 1 OF 4 FOR (B)(4).