JAZZ LOCK

Additional Manufacturer Narrative

VISUAL EXPERTISE OF JAZZ LOCK RETURNED WAS PERFORMED BY IMPLANET AND SHOWED THAT THE PEEK INSERTS WERE INSUFFICIENTLY INSERTED INTO THE BASE. THIS MAY EXPLAIN THE SURGEON'S FINDINGS DURING THE REOPERATION. A MEETING WITH THE SURGEON WAS ORGANISED IN ORDER TO REINFORCE THE SURGICAL TECHNIQUE AND HE CONTINUES USE THE JAZZ LOCK ALMOST WEEKLY IN 2025.

Description of Event or Problem

2X JAZZ BAND AND 2X JAZZ LOCK USED IN A POSTERIOR LUMBAR FUSION, (B)(6) 2024. BANDS PASSED AROUND THE UIV+1 (L1) SPINOUS PROCESS AND TENSIONED AROUND THE ROD BILATERALLY. REOPERATION ON (B)(6) 2024. SURGEON NOTED THAT IN ONE LOCK CONNECTOR BOTH PORTIONS OF THE BAND WERE OUT OF THE LOCK CONNECTOR AND IN FOR THE SECOND LOCK CONNECTOR ONE PORTION OF THE BAND REMAINED IN THE CONNECTOR. THE REASON FOR THE RE-OPERATION WAS PATIENT WAS STILL SYMPTOMATIC, SO THE REOPERATION WAS FOR FURTHER DECOMPRESSION, AND THEY FOUND SLIPPING OF THE BAND UPON INSPECTION. DUE TO THE PATIENT'S PATHOLOGY, THE SURGEON EXTENDED THE FIXATION UP ONE LEVEL WITH PEDICLE SCREWS AND RODS. SURGICAL INDICATION : LUMBAR DECOMPRESSION AND FUSION. TYPE OF CONSTRUCT: PLIF + PEDICLE SCREWS + JAZZ LOCK. THIS REPORT IS MADE AT THAT DATE FURTHER TO THE OBSERVATIONS WRITTEN IN A FORM FDA 483 BY (B)(6), FDA INVESTIGATOR ON JULY 4, 2025.