INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2012-02153
- Event Type
- Injury
- Date Received
- November 13, 2012
- Report Date
- January 9, 2017
- 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
(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.
THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # M110803AAG AND # M10806AAI. EXPIRY DATE FOR LOT M110803AAG IS 3/1/2011; EXPIRY DATE FOR LOT M110806AAI IS 3/1/2012. MANUFACTURE DATE FOR LOT M110803AAG IS 4/3/2009; MANUFACTURE DATE FOR LOT M110806AAI IS 1/11/2010.
(B)(4).
IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR MYELOGRAM AND CT, WHICH WAS INTERPRETED TO INDICATE "NORMAL LUMBAR MYELOGRAM." CT - "BASIC IMPRESSION IS THAT THIS IS TOTALLY A NORMAL STUDY ALTHOUGH THERE IS A LITTLE QUESTION ABOUT THE LEFT SIDE OF THE L3-4 DISC IN ONE SINGLE VIEW WHERE THERE IS SOME INDISTINCTNESS BUT A DEFINITIVE LESION CANNOT BE IDENTIFIED." APPROXIMATELY 2 YEARS LATER, A LUMBAR MRI WAS INTERPRETED TO INDICATE "VERTEBRAL HEIGHT AND ALIGNMENT ARE MAINTAINED. SLIGHT BULGES OF THE DISC ARE AGAIN SEEN AT L3-4 AND L5-S1. BOTH OF THESE BULGES ARE SLIGHTLY MORE PROMINENT TO THE LEFT AND THERE IS MINIMAL ENCROACHMENT ON THE LEFT NEURAL FORAMINA AT EACH OF THESE TWO LEVELS. I DO NOT SEE ANY OTHER AREAS OF FORAMINAL ENCROACHMENT. THERE IS NO SPINAL STENOSIS. A DEGREE OF DEGENERATIVE CHANGES SIMILAR TO PRIOR EXAM WITH MINIMAL OSTEOPHYTE FORMATION AND MILD FACET HYPERTROPHY AT EACH LEVEL. I DO NOT DETECT ANY SIGNIFICANT CHANGES COMPARED TO THE PRIOR EXAM." THE PATIENT UNDERWENT SURGERY FOR FACET JOINT ARTHRITIS L5-S1 AND DEGENERATIVE DISC DISEASE L5-S1. PROCEDURE WAS FOR POSTEROLATERAL LUMBAR ARTHRODESIS L5-S1, POSTERIOR LUMBAR INTERBODY ARTHRODESIS L5-S1, NON-SEGMENTAL FIXATION L5-S1, AND INSERTION OF INTERBODY CAGE DEVICE L5-S1. LOCAL BONE AND RHBMP-2/ACS WAS INSERTED INTO THE DISC SPACE AND THEN A CAGE WAS INSERTED. POSTERIOR FIXATION WAS USED. 103 DAYS POST-OP, A LUMBAR MRI WAS PERFORMED AND INTERPRETED TO INDICATE "THE LUMBAR SPINE DEMONSTRATES NORMAL ALIGNMENT. THERE ARE PEDICLE SCREWS SEEN IN L5 ANDS1. I BELIEVE THERE IS A METAL SPACER OF THE DISC AT L5-S1. THERE IS A LARGE AMOUNT OF BONE MARROW EDEMA INVOLVING THE INFERIOR 1/2 OF THE LS VERTEBRAL BODY AND MINIMALLY OF THE SUPERIOR PORTION OF S1. THIS IS EVIDENCED BY LOW SIGNAL ON T1 AND HIGH SIGNAL ON T2 WEIGHTED IMAGES. THERE IS ENHANCEMENT ON BOTH SIDES OF THE DISC AND INVOLVING THE DISC TO A LESSER EXTENT AT L5-S1. THIS PATTERN IS CONSISTENT WITH DISCITIS AND OSTEOMYELITIS. THERE IS NO EVIDENCE OF EPIDURAL ABSCESS. ON THE AXIAL IMAGES AT L1-2, L2-3, THERE IS NO SIGNIFICANT CENTRAL STENOSIS OR NEURAL FORAMINAL STENOSIS. AT L3-4, THERE IS NO SIGNIFICANT CENTRAL STENOSIS OR NEURAL FORAMINAL STENOSIS, BUT THERE IS SOME FACET ARTHROPATHY. AT L4-5, THERE IS MINIMAL DISC BULGE AND FACET ARTHROPATHY CAUSING MINIMAL CENTRAL STENOSIS. AT L5-S1, THERE IS NO SIGNIFICANT CENTRAL STENOSIS, BUT THERE IS FACET ARTHROPATHY WITH THE PEDICLE SCREWS TRANSFIXING THE FACET JOINTS." 104 DAYS POST-OP, A LUMBAR CT WAS PERFORMED AND INTERPRETED TO INDICATE "ALIGNMENT IS NORMAL. THE PATIENT IS POST LUMBOSACRAL FUSION WITH A PLATE AND SCREWS AT THEL5-S1 LEVEL. THERE IS WIDENING AND IRREGULARITY OF THE L5-S1 DISC SPACE. THE INFERIOR PORTION OF THE BODY OF L5 APPEARS ERODED AND THE SUPERIOR PORTION OF S1 IS SCLEROTIC. THERE IS A METALLIC DENSITY IN THE CENTRAL PORTION OF THE DISC SPACE. A VACUUM PHENOMENON IS PRESENT AT THE T11-T12 LEVEL. REPORTEDLY, THE PATIENT DEVELOPED "SERIOUS PROBLEMS, INCLUDING PAIN, NERVE INJURIES, MENTAL ANGUISH," AND IS "WORRIED THAT THINGS WILL KEEP GETTING WORSE."
IT WAS REPORTED THAT ON: (B)(6) 2009: THE PATIENT UNDERWENT AN MRI WHICH SHOWED A LARGE AMOUNT OF BONE MARROW EDEMA INVOLVING THE INFERIOR HALF OF THE L5 VERTEBRAL BODY AND MINIMALLY THE SUPERIOR PORTION OF S1. THE PATIENT ALSO UNDERWENT CT SCAN WHICH SHOWED WIDENING AND IRREGULARITY OF THE L5-S1 DISC SPACE. THE INFERIOR PORTION OF THE L5 BODY APPEARED ERODED AND THE SUPERIOR PORTION OF S1 WAS SCLEROTIC. ON (B)(6) 2009: THE PATIENT UNDERWENT LUMBAR CT AND AN OSTEOPHYTE FORMATION AT L5-S1 WAS NOTED.
IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT SPINE FUSION SURGERY ON THE LUMBAR REGION OF HER SPINE FROM VERTEBRAE L5 TO S1 USING RHBMP-2 FROM A POSTERIOR APPROACH. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE (I.E., IN THE DISC SPACE). PATIENT'S POST-OPERATIVE PERIOD WAS MARKED BY PROGRESSIVELY INCREASING PAIN IN HER LOWER BACK, WITH PAIN RADIATING DOWN HER LEFT LEG AND INTO HER FOOT. SEVERE PAIN AND SYMPTOMS ULTIMATELY COMPELLED PATIENT TO UNDERGO A RISKY, PAINFUL AND COSTLY REVISION SURGERY ON (B)(6) 2010.
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 | M110803AAG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |