TRABECULAR METAL SHAPES

Additional Manufacturer Narrative

INVESTIGATION IN PROCESS. C4-5 / 08-100-01051, LOT: 61396260, TM100 11X11X5MM, EXP DATE: 11/30/2014, MFR DATE: 11/2009; C5-6 / 08-100-01051, LOT: 61003805, TM100 11X11X5MM, EXP DATE: 05/31/2013, MFR DATE: 05/2008; C6-7 / 08-100-01061, LOT: 61420627, TM100 11X11X6MM.

Description of Event or Problem

ON (B) (6) 2010, DR. (B) (6) AT (B) (6) MEDICAL CENTER COMPLETED A 4L (C3-7) ACDF ON A (B) (6) FEMALE ((B) (6)) FOR MULTILEVEL DDD WITH FACET DISEASE, DISC PROTRUSION LT C6-7/C7-T1 AND STENOSIS C3-6. SHE HAD MYELOMALACIA OF CORD AT C4-5, C5-6 HAD SPUR + DISC INVOLVEMENT. SHE HAD POSTERIOR NECK PAIN WITH LT RADICULOPATHY. (B) (6) SMOKER 1-1/2 PPD SINCE AGE(B) (6) (FOR 24 YEARS). FLUORO FILMS LOOKED GOOD. THE ITEMS IN SECTION 7 WERE IMPLANTED. PT AWOKE MOVING ALL EXTREMITIES. ON (B) (6) 2010, PT RETURNS TO OR WITH WEAKNESS OF LEFT ARM AND SCHEDULED FOR EXPLORATION C4-5/5-6. TRINICA PLATE AND 10 SCREWS REMOVED WITHOUT DIFFICULTY, CASPAR PINS + RETRACTOR PLACED FOR DISTRACTION AND TM100'S REMOVED FROM C4-5 AND C5-6 ONE AT A TIME - NO DIFFICULTY - WITH DECOMPRESSION TO FOLLOW. THE FOLLOWING LEVELS WERE REVISED WITH .. C4-5 TM100 11X11X8MM 08-100-01081, LOT: 61349942; C5-6 TM100 11X11X8MM, 08-100-01081, LOT: 61093516 (FILLED WITH AUTOGRAFT FROM CERVICAL DECOMPRESSION).