MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problems Fistula (1862); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Rash (2033); Increased Sensitivity (2065); Skin Irritation (2076); Burning Sensation (2146); Tingling (2171); Pressure Sores (2326); Numbness (2415); Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

(b)(6).It is unknown which product caused the event.(b)(4) (non-union).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2015: all hardware of the broken device was removed and new instrumentation was placed with additional levels fused up to t3.Post-operatively patient had numbness and tingling down his leg.Patient had a rash all over his body and had been ill since the surgery.Patient had anal fistula, perineal numbness, no sensation to the rectum immediately after surgery.Patient was placed on steroids and now had abnormal bowel movements.Patient had pulmonary nodes in his lungs and suffered from vasculitis.Patient had allergy testing and was found to be allergic to nickel.Cobalt chrome with nickel was used in the patient's surgery as informed by the surgeon but the surgeon didn't name the device.Patient needed to see an immunologist to have metal testing specific to devices.Patient had hives and numbness in left foot, hand and leg.On (b)(6) 2015: patient presented with pre-op and post-op diagnosis of kyphosis.Patient underwent decompression and posterior lumbar fusion.Patient underwent the following procedures were performed: instrumentation, thoracic to pelvis, posterior column osteotomies, pedicle subtraction, lumbar osteotomy.As per the patient they were going to remove a device and then add to his existing device in his spine.Intra-op o-arm x-rays were taken of thoracic spine.On (b)(6) 2015: patient presented with following pre-op and post-op diagnosis: left hand compartment syndrome.Patient underwent following procedures: left hand fasciotomies and carpal tunnel release, irrigation and debridement.Comments: pressure ulcer on (b)(6) 2015: patient presented with following pre-op and post-op diagnosis: malpositioned right posterior pelvic screw.Patient underwent following procedures:reposition of pelvis screw.Skin assessment: harm, broken, reddened, rash.Patient had unexplainable immune system hypersensitivity, allergic reactions.He believed that all his post-op ailments were truly due to metal allergies causing his immune system to not only cause fusion failure and necrosis effects at implant site t-4 - sacrum/pelvis 2 months after being on steroids patient had puss filled sores that burned like if acid was poured on them.He took last step down steroid pill as of (b)(6) 2016.He anticipates the vasculitis will return.Surgeon thought of it as shingles but later physician was the first to diagnose it as vasculitis.In effect his immune system was attacking his blood vessels.He had massive tingling in left hand/left leg, both have become extremely cold and sensitive.He doesn't feel typical numbness from surgical nerve disruption.He had a pounding, throbbing, pulsating pain with non stop massive tingling.He believed that all his post op allergic reactions and immune response was due to his allergy to nickel and vanadium.

Manufacturer Narrative

X-ray review: post op from spinal construct patient had hypersensitivity reaction with multiple side effects.Allergy testing revealed reactivity to vanadium and nickel.It is unknown if patient was aware of this allergy pre-op.Root cause: patient factors.

Event Description

Patient continues to have complications with his recovery.Patient is having increased pain throughout his implant site and very serious headaches.Patient continues to have gastrointestinal issues, strange rashes and even blisters showing up continually.Test revealed that patient is allergic to nickel, vanadium and aluminium.Patient was implanted with rods, cross-links, set screws, screws in 2010 (during removal surgery) which had titanium, aluminium, vanadium, cobalt, chromium, molybdenum as its constituents.This appears to be same materials which were implanted during a surgery performed on (b)(6) 2015 and hence per patient, it eliminates metal allergy issues.Per patient: ¿ i've learned my dura was lacerated during surgery ((b)(6) 2015) and bled into my cerebral fluid, thus causing arachnoiditis capable of triggering an immune response such as i had.¿.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5626841
• MDR Text Key: 44278303
• Report Number: 1030489-2016-01276
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/12/2016
• Supplement Dates FDA Received: 05/19/2016; 01/05/2017; 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention