INFUSE BONE GRAFT

Report

Report Number: 1030489-2012-01942
Event Type: Injury
Date Received: October 23, 2012
Report Date: September 24, 2012
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NEK
PMA / PMN Number: P000058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT L4-5 AND L5-S1 DEGENERATIVE DISC DISEASE WITH SEGMENTAL COLLAPSE, FORAMINAL STENOSIS AND RADICULOPATHY. AN ALIF WAS PERFORMED USING AN ANTERIOR STALIF CAGE, SCREWS AND SEGMENTAL FIXATION, RHBMP-2/ACS AND FORMAGRAFT. THE BMP AND FORMAGRAFT WERE PLACED WITHIN THE INTERBODY CAGE AT EACH LEVEL. THERE WERE NO NOTED COMPLICATIONS. AT 8 DAYS POST-OP, THE PATIENT PRESENTED FOR POST-OP EVALUATION. PER THE PHYSICIAN'S NOTES, "HE IS DOING EXTREMELY WELL. HE IS AMBULATING INDEPENDENTLY. HE HAS NO PROBLEMS." AT 46 DAYS POST-OP, THE PATIENT PRESENTED FOR 6-WEEK POST-OP FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE IS ESSENTIALLY ASYMPTOMATIC WITH NO LEG PAIN. HE DENIES NUMBNESS, TINGLING OR WEAKNESS. HE IS WALKING A MILE AND A HALF AT LEAST PER DAY." AT 95 DAYS POST-OP, THE PATIENT PRESENTED FOR 3 MONTHS POST-OP VISIT. PER THE PHYSICIAN'S NOTES, "HE IS ESSENTIALLY ASYMPTOMATIC. HE DENIES NUMBNESS, TINGLING OR WEAKNESS. HE HAS NO SIGNIFICANT BACK PAIN" X-RAYS DOCUMENT PROPER PLACEMENT OF IMPLANTS." AT 188 DAYS POST-OP, THE PATIENT PRESENTED FOR 6 MONTH POST-OP VISIT. PER THE PHYSICIAN'S NOTES, THE PATIENT "IS ASYMPTOMATIC IN HIS BACK. HE HAS NO BACK OR LEG PAIN. HE IS PLEASED WITH THE RESULTS" HE CONTINUES TO COMPLAIN OF PAIN IN THE LEFT SHOULDER AND NECK ON EXAM, THERE HAS BEEN NO ACUTE LOSS OF MOTOR OR SENSORY FUNCTION. X-RAYS OF HIS NECK SHOW THAT HE HAS MARKED NARROWING AT C5-C6. X-RAYS OF HIS LOWER BACK SHOW A SOLID FUSION. AT 610 DAYS POST-OP, AN MRI OF THE CERVICAL SPINE INDICATED AT C3-4 A 3.0MM DISC BULGE FLATTENS THE THECAL SAC. THE C4-C5 LEVEL REVEALS FLATTENING OF THE THECAL SAC WITH MILD NARROWING OF THE RIGHT NEUROFORAMEN. AT C5-C6 MILD CANAL STENOSIS IS SEEN WITH MODERATE BILATERAL FORAMINAL NARROWING. AT C6-C7 A 4.0MM LEFT PARASAGITTAL AND FORAMINAL DISC PROTRUSION IS SEEN IMPINGING UPON THE LEFT C7 NERVE ROOT SLEEVE WITH SEVERE NARROWING OF THE LEFT AND MODERATE NARROWING OF THE RIGHT NEUROFORAMEN. AT 634 DAYS POST-OP, THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, "THE PATIENT HAS LOW TESTOSTERONE SINCE (B)(6) 2010. THE PATIENT TAKES INJECTIONS EVERY 2 WEEKS. THE PATIENT STATES THAT HE DOES NOTICE A DIFFERENCE IN HIS ENERGY LEVELS AND HE IS NOT AS FATIGUED AND HIS MUSCLE MASS HAS IMPROVED AS WELL. THE PATIENT DENIES HAVING ANY HYPERGONADISM. THE PATIENT CONTINUES TO HAVE ONGOING CHRONIC SPASMS OF THE CERVICAL THORACIC AND LUMBAR SPINE. THE PATIENT COMPLAINS OF RADICULAR PAIN TO BILATERAL BICEPS BUT THERE IS NO RADICULAR PAIN OF THE LUMBAR SPINE SINCE FUSION. "X-RAYS OF THE LUMBAR SPINE INDICATE" THERE IS A COMPLETE LOSS OF LORDOTIC CURVE. THERE ARE A TOTAL OF 4 SCREWS WITHOUT LUCENCY AROUND THE SCREWS AND THEY APPEAR WELL IMBEDDED AND THAT THE SCREWS FUSED TOGETHER L3, L4-L5, AND S1. THERE IS A COMPLETE LOSS OF DISC SPACE AT L4-L5 WITH A SPONDYLOLISTHESIS AT L4-L5. AT 659 DAYS POST-OP, THE PATIENT PRESENTED WITH LOWER BACK PAIN AND NECK PAIN. AT 700 DAYS POST-OP, AN MRI OF THE LUMBAR SPINE INDICATED ANATOMIC ALIGNMENT OF THE POSTOPERATIVE LUMBAR SPINE IS SEEN. THERE IS NO EVIDENCE OF ARACHNOIDITIS. AT L2-3 A 3.0MM DISC BULGE FLATTENS THE THECAL SAC WITH MODERATE NARROWING OF THE LEFT NEUROFORAMEN. AT L3-4 MODERATE NARROWING OF THE LEFT WITH MILD NARROWING OF THE RIGHT NEUROFORAMEN IS PRESENT. THE L4-L5 LEVEL REVEALS A SOLID ANTERIOR INTERBODY FUSION. FACET JOINT ARTHROSIS WITH MILD BILATERAL FORAMINAL NARROWING IS PRESENT. AT L5-S1 A SOLID ANTERIOR INTERBODY FUSION IS SEEN. A RESIDUAL OR RECURRENT 6.0 MM LEFT SUBARTICULAR AND FORAMINAL DISC PROTRUSION IS NOTED IMPINGING UPON THE EXITING LEFT L5 NERVE ROOT SLEEVE WITH MODERATE BILATERAL FORAMINAL ENCROACHMENT. THIS DISC PROTRUSION IS WELL SEEN ON SAGITTAL IMAGES. AT 778 DAYS POST-OP, THE PATIENT PRESENTED WITH PAIN IN THE NECK, UPPER LEFT ARM AND LEFT HAND, AND UPPER BACK, LOWER BACK, AND RIGHT SCAPULA WITH SOME RADIATION TO THE LEFT UPPER EXTREMITY. THE PATIENT WAS DIAGNOSED WITH POSTLAMINECTOMY SYNDROME. AT 1021 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN RADIATING TO BOTH BUTTOCKS AND THE PROXIMAL ASPECT OF BOTH POSTERIOR THIGHS. A CT SCAN INDICATED SOLID ANTERIOR AND POSTERIOR FUSION L4-5 AND L5-S1. MODERATE BILATERAL FORAMINAL STENOSIS AT L5-S1 WITH OSTEOPHYTES PRODUCING IMPRESSION ON BOTH L5 NERVE ROOTS. LEFT PARACENTRAL OSTEOPHYTE AND ADJACENT SOFT TISSUE CONSISTENT WITH DISC OR SCAR WITH IMPRESSION ON THE LEFT S1 NERVE ROOT. RIGHT-SIDED DISC HERNIATION AT L3-4 WITH COMPRESSION OF THE RIGHT L3 AND L4 NERVE ROOTS. MILD BILATERAL LATERAL RECESS STENOSIS AT L2-3 WITH IMPRESSION ON THE L3 NERVE ROOTS BY DISC BULGE. X-RAYS OF THE LUMBAR SPINE INDICATED EXPECTED POSTOPERATIVE APPEARANCE OF L4-S1 FUSION. MILD DISC SPACE NARROWING AT L1-2 TO L3-4 WITH MILD S-SHAPED CURVATURE. ALLEGEDLY, POST-OPERATIVELY, THE PATIENT HAS DEVELOPED BONE SPURS, ECTOPIC BONE GROWTH, CHRONIC PAIN AND NUMBNESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSE BONE GRAFT	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	NEK	MEDTRONIC SOFAMOR DANEK USA, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	STALIF CAGE, SCREWS, SEGMENT FIXATION, FORMAGRAFT