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: SCHULZ R. ET AL (2014), DOES KYPHOTIC DEFORMITY CORRELATE WITH FUNCTIONAL OUTCOMES IN FRACTURES AT THE THORACOLUMBAR JUNCTION TREATED BY 360 DEGREES INSTRUMENTED FUSION?, EUR J ORTHOP SURG TRAUMATOL, VOLUME 24. SUPPLEMENT 1. PAGES S93-S101, (CHILE). THE GOAL OF THIS STUDY IS TO INVESTIGATE WHETHER LOCAL KYPHOSIS CORRELATES WITH THE HANNOVER AND THE OSWESTRY SCORES IN PATIENTS TREATED SURGICALLY FOR FRACTURES AT THE THORACOLUMBAR JUNCTION (TLJ), AND GIVEN SUCH CASE, TO DETERMINE THE DEGREE OF KYPHOSIS SIGNIFICANT FOR SUCH SCORES. BETWEEN JANUARY 1993 TO DECEMBER 2001, 94 PATIENTS WHO WERE TREATED SURGICALLY FOR TLJ FRACTURES WERE INCLUDED IN THE STUDY. THERE WERE 52 MALE AND 42 FEMALE PATIENTS WITH A MEAN OF 49.06 YEARS (RANGE 20-77 YEARS) AT FOLLOW-UP. ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN DEPUY HARMS CAGE (JOHNSON AND JOHNSON, ACROMED) FILLED WITH AUTOGENOUS BONE GRAFT FOR ANTERIOR SUPPORT. UNKNOWN DEPUY MOSS-MIAMI PEDICULAR SCREWS (MOSS-MIAMI, J&J, ACROMED), WERE THEN PLACED POSTERIORLY UNDER COMPRESSION AGAINST THE CAGE, AND POSTEROLATERAL AUTOGENOUS BONE WAS ALSO USED. THE PATIENTS WERE EVALUATED AFTER A FOLLOW-UP PERIOD OF 2 TO 10 YEARS; MEAN FOLLOW-UP OF 71.6 MONTHS (RANGE 26.8¿127.6 MONTHS). FUNCTIONAL EVALUATION BASED ON THE OSWESTRY AND HANNOVER SCORES (HS) WAS PERFORMED. ADDITIONALLY, PATIENTS UNDERWENT CLINICAL AND RADIOLOGICAL EVALUATION. COMPLICATIONS WERE REPORTED AS FOLLOWS: 51. 1 PERCENT OF THE PATIENTS REPORTED SOME DISCOMFORT OR PAIN AT THE SURGICAL SITE, WHICH AVERAGED 34 MM IN THE VISUAL ANALOG SCALE. 6 PATIENTS HAD LOCAL KYPHOSIS THAT ASCENDED TO 20 DEGREES OR MORE. PAIN IN ALL THESE SIX PATIENTS WAS HIGHER THAN THE AVERAGE, AND THE OSWESTRY AND HANNOVER SCORES WERE POORER. DEPUY SPINE PRODUCT: THIS REPORT IS FOR THE UNKNOWN DEPUY HARMS CAGE (JOHNSON AND JOHNSON, ACROMED). THIS IS REPORT 1 OF 2 FOR (B)(4).