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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE INC. MALIBU SPINAL SYSTEM MALIBU POLYAXIAL SCREW, 6.5 X 45MM

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SEASPINE INC. MALIBU SPINAL SYSTEM MALIBU POLYAXIAL SCREW, 6.5 X 45MM Back to Search Results
Model Number 12-6545
Device Problems Corroded (1131); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2020
Event Type  malfunction  
Manufacturer Narrative
The photos provided by the surgeon demonstrate the implants have localized corrosion where the incorrect material was located. The corrosion is due to the incorrect material used in several lots of the malibu implant, which was previously discovered and recalled in march, 2009 per recall notice - 20325933/13/2009-001-r. The recall did not recommend a revision to remove the implants unless it was pathologically warranted. The implanted construct did not fail and the patient did not experience an inflammatory response from the corrosion; the decision to revise and remove these implants occurred because of the pathology at the adjacent level. These results are in line with guidance provided in the recall and no further action is warranted at this time. Indications for use: the intended use of the malibu, ucr, and newport systems, when used as a pedicle screw spinal system or spondylolisthesis spinal fixation device system, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (ddd) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (l3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a spondylolisthesis spinal fixation device system), spondylolisthesis, trauma (i. E. , fracture or dislocation), spinal stenosis, deformities or curvatures (i. E. , scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and/or failed previous fusion. The intended use and indications of the malibu and ucr systems, when used as a spinal interlaminal fixation orthosis or hook spinal system, are limited to t1-l5 and are as follows: degenerative disc disease (ddd) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (i. E. , fracture or dislocation), spinal stenosis, deformities or curvatures (i. E. , scoliosis, kyphosis, and/or lordosis), tumor, pseudarthosis, and/or failed previous fusion. Implant materials: titanium 6aluminum-4vanadium (6al-4v) eli, per astm f136, cobalt 28chromium-6molybdenum per astm f1537, 35cobalt 35nickel-20chromium-10molybdenum per astm f562. Contraindications: any medical or surgical condition which would preclude the potential benefit of spinal implant surgery is a contraindication. The following conditions may reduce the chance of a successful outcome and should be taken into consideration by the surgeon. This list is not exhaustive: absolute contraindications: infection in or around the operative site, allergy or sensitivity to implant materials, any case not described in the indication. Relative contraindications: local inflammation, morbid obesity, pregnancy, fever or leukocytosis, prior fusion at the level(s) to be treated, grossly distorted anatomy due to congenital abnormalities, rapid joint disease, bone absorption, osteopenia, and/or osteoporosis, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (wbc), or a marked left shift in the wbc differential count, any case not requiring bone graft and fusion or where fracture healing is not required, patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition, unsuitable or insufficient bone support, bone immaturity, the patient's activity level, mental condition, occupation and/or a patient unwilling to cooperate with the postoperative instructions, any case where implant utilization would interfere with anatomical structures or expected physiological performance, use of incompatible components and/or materials from other systems. Possible adverse events: like other spinal system implants, the following adverse events are possible. This list is not exhaustive: delayed union or nonunion (pseudarthrosis), bending, disassembly or fracture of implant and components, loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain, pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin, dural leak requiring surgical repair, cessation of growth of the fused portion of the spine. Subsidence of the implant into adjacent bone, loss of proper spinal curvature, correction, height and/or reduction, increased biomechanical stress on adjacent levels. Improper surgical placement of the implant causing stress shielding of the graft or fusion mass, intraoperative fissure, fracture, or perforation of the spine, postoperative fracture due to trauma, defects, or poor bone stock, serious complications associated with any surgery may occur. These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death. Warnings and precautions: patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without previous surgery. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the l5-s1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. The implantation of this system should be performed only by experienced spinal surgeons with specific training in the use of this device because this is a technically demanding procedure presenting a risk of serious injury to the patient. Based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. Which may impact the performance of the system ensure all implants, components or instruments are sterilized prior surgery. The use of non-sterile devices may lead to inflammation, infection or disease. Implants should never be reused under any circumstances. A used implant should be discarded. While the implant may appear undamaged, it may have small defects or internal stress patterns and if implanted, could fail to perform as intended and pose safety risks to the patient. The risks include, but are not limited to, mechanical failure, breakage, difficulty with implantation, incompatibility with mating components and infection. Mechanical and clinical testing indicates that the majority of the axial or compressive load is carried in the anterior column of the spine. When posterior instrumentation is utilized for spinal stability, adequate anterior column support is necessary, either by surgical intervention or existing anatomy. Failure to maintain a stable anterior column when using posterior instrumentation may lead to overstress of the posterior construct and implant failure. Postoperative warnings: surgeons should advise patients regarding the risks of surgery and the importance of post-operative compliance. The patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be advised that implants may bend, break or loosen despite restriction in activity. The patient should be advised to avoid mechanical vibrations that may loosen the device. The patient should be advised not to smoke or consume alcohol during recovery.
 
Event Description
On (b)(6) 2020 seaspine was informed of a malibu spinal system removal surgery. The index surgery was (b)(6) 2008. The primary reason for the removal was pathology at an adjacent level and not due to failure of the implant. During the removal, corrosion was discovered where the rod and screw interfaced. The distributor expressed the surgeon's concern regarding the malibu screw recall that took place shortly after the index surgery. The referenced recall was due to the manufacturer using the wrong metal inside the tulip head of the screw.
 
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Brand NameMALIBU SPINAL SYSTEM
Type of DeviceMALIBU POLYAXIAL SCREW, 6.5 X 45MM
Manufacturer (Section D)
SEASPINE INC.
5770 armada drive
carlsbad, ca
Manufacturer (Section G)
SEASPINE INC.
5770 armada drive
carlsbad, ca
Manufacturer Contact
audrey mudderman
5770 armada drive
carlsbad, ca 
2165137
MDR Report Key9835491
MDR Text Key227199773
Report Number3012120772-2020-00025
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10889981001155
UDI-Public10889981001155
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number12-6545
Device Catalogue Number12-6545
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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