COBALT CHROME RODS
Received Jun 27, 2018 · Event occurred Jun 1, 2017
Report MW5078098 · MDR key 7645224
Device
Generic name
Appliance, Fixation, Spinal Interlaminar
Manufacturer
Medtronic Puerto Rico Operations Co., HumacaoProduct problems
- Break
Patient
Not reported
- Death
- Pain
- Discomfort
- Death
- Pain
- Discomfort
Narrative
Description of Event or Problem
MY HUSBAND HAS RODS[MEDTRONIC] (12 LEVELS FUSED W/ RODS) PUT IN ON (B)(6)2016. IN (B)(6) 2017 STARTED HAVING PAIN, HAD XRAY, IN (B)(6) 2017 RODS BROKEN IN 2 PIECES. HAD PARTIAL RODS REMOVED AND REPLACED WITH ADD'L RODS PUT IN ON (B)(6) 2017. IN (B)(6) HAD FIRST XRAY TO SEE HOW WAS HEALING AND THE RODS THAT WERE LEFT IN L/4-S/2/3) FROM FIRST RODS WERE BROKEN IN 3 PLACES. ONLY 4 MONTHS OUT FROM 2ND SURGERY. THIS PLAYED WITH MY HUSBAND'S PSYCHE AND WAS EXPERIENCING EXTREME PAIN. STARTED HAVING BREATHING PROBLEMS FROM THE EXTREME CROOK IN MY HUSBAND'S BACK. MY HUSBAND TRIED NUMBING HIMSELF MENTALLY TO NOT THINK ABOUT FACING A 3RD SURGERY. HE PASSED AWAY ON (B)(6) 2018. THESE PRODUCTS NEED REVIEW. COBALT CHROME RODS MEDTRONIC'S PRODUCTS.