4.5/5.0 OPEN LEFT OFFSET LUMBAR HOOK, 5MM
Received Jul 13, 2026 · Event occurred Jun 11, 2026
Report 3006460162-2026-00032 · MDR key 25800455
Device
Generic name
4.5/5.0 Open Left Offset Lumbar Hook, 5mm
Manufacturer
OrthopediatricsModel number
00-1600-3302Product problems
- Unintended Movement
Patient
6 YR · Male
- Failure of Implant
Narrative
Description of Event or Problem
THE PATIENT UNDERWENT SURGERY ON (b)(6) 2025, WITH A GROWTH SYSTEM, FEATURING DISTAL PEDICLE FIXATION AT L3, L4, AND L5; PROXIMAL PEDICLE FIXATION AT T3 AND T4; BILATERAL WEDDING BAND CONNECTORS (CODE 00-1600-6900); AND 4.5MM COBALT-CHROME RODS, BENDED TO ACCOMMODATE PROXIMAL KYPHOSIS AND DISTAL LORDOSIS.ON (b)(6) 2026, THE PATIENT UNDERWENT A SECOND SURGERY. FOUR LOOSE PROXIMAL SCREWS WERE FOUND AND REMOVED. HOOKS WERE INSTALLED AT T1 AND T3 IN BILATERAL COMPRESSION; BILATERAL LAMINAR HOOKS AT T4; A LAMINAR HOOK AT T6; AND A PEDICLE SCREW AT T6, ALSO IN COMPRESSION. THE RODS WERE REPLACED WITH 5.5MM TITANIUM, PROVIDING GREATER KYPHOSIS. THE LEFT LAMINAR HOOK AT T4 WAS LOST DUE TO A LAMINAR FRACTURE. TWO CROSSLINKS WERE INSTALLED TO THE NEW PROXIMAL ANCHORAGE.THIRD SURGERY ON (b)(6) 2026. COMPLETE LOOSENING OF THE LEFT HOOK AT T3, PROXIMAL TO THE CROSSLINK, WAS OBSERVED, WITH MALPOSITION OF THE SET SCREW. THE HOOK WAS REMOVED. MALPOSITION OF THE SET SCREW OF THE LEFT HOOK AT T2 WAS OBSERVED, AND WHEN CHANGING THE SCREW AND USING THE 12N TORQUE LIMITER, THE SET SCREW WAS TILTED AND ITS THREADS BROKE.