A BILATERAL APPROACH WAS PERFORMED. THE MIDLINE OSTEOTOME DURING THE PROCEDURE BECAME STUCK IN THE VERTEBRAE. THE ARTICULATING TIP BECAME "KINKED" ON IMPACTION WITH THE MALLET. UPON REALIZING THIS, THE SURGEON TRIED TO REMOVE THE MLO. THE MLO WAS NOT MOVING AT ALL AND EXTREME FORCE WAS APPLIED TO TRY AND REMOVE OF APPROXIMATELY 10 MINUTES. EVENTUALLY THE INTRODUCER AND THE MLO CAME OUT LEAVING THE ARTICULATING TIP REMAINING IN THE PATIENT. THE MIDLINE OSTEOTOME WAS BROKEN INSIDE THE VERTEBRAL BODY AND THE TIP GOT LOST BETWEEN THE VERTEBRAL BODY AND THE PEDICLE.
N
Patient 1
DEVICE HISTORY RECORD REVIEW: PN 2483, ASSEMBLY OF VERTECOR MIDLINE CEMENT STAGING OSTEOTOME-LONG, LZ-FORM, REVISION AB, LOT TLM-1406-18 ((B)(4)). NO ANOMALIES WERE RELATED TO THE CUSTOMER COMPLAINT UPON REVIEW OF THE DHR DOCUMENTATION. TESTS REVIEWED: (B)(4), REV AM - END ITEM AUDIT TESTING - MECHANICAL TESTING SPECIFICATIONS WERE ALL MET FOR THE LOT. BONE CEMENT TESTING - TESTING SPECIFICATIONS WERE ALL MET. RAW MATERIAL EVALUATION OF DEVICE: PNPS 3765 REVISION AE, FIRST FRACTURE KIT, BLISTER PACK, SHORT (VM) LINKED O MATERIAL SPECIFICATIONS: (B)(4) REVISION AA MIDLINE OSTEOTOME ASSEMBLY SHORT, (B)(4) REVISION AB; REQUIRES THE RAW MATERIAL (B)(4). MEDICAL GRADE 316 STAINLESS STEEL; SIMILAR TO PEDICLE SCREWS, ARE COMMONLY USED AS PERMANENT IMPLANTS IN FUSION SPINE SURGERY. SEE SCANNED PAGE.