MALIBU
Report
- Report Number
- 3012120772-2020-00005
- Event Type
- Injury
- Date Received
- February 12, 2020
- Date of Event
- January 13, 2020
- Report Date
- February 12, 2020
- Manufacturer
- SEASPINE INC.
- Product Code
- NKB
- UDI-DI
- 10889981008666
- PMA / PMN Number
- K122571
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
DURING THE REVIEW OF THE DHR FOR LOT MA63345E, IT WAS CONCLUDED THAT THE PRODUCT WAS INSPECTED AND ACCEPTED FOR USE BY THE QUALITY CONTROL TEAM ON 5/31/2016 AND MET ALL SPECIFIED PARAMETERS OF THE RECEIVING INSPECTION REPORT WITH NO ASSOCIATED NONCONFORMANCE SPECIFIC TO THE PRODUCT ISSUE. THE SCREWS IN QUESTION WERE RECEIVED BY SEASPINE AND EVALUATED BY ENGINEERING ON FEBRUARY 5, 2020. AFTER EXAMINING THE FAILED HARDWARE AND THE POST-OPERATIVE IMAGING OF THIS CASE, IT CAN BE SEEN THAT THE END OF THE PREVIOUS INSTRUMENTATION CONCLUDED AT T12 WITH BI-LATERAL 5.5 MM DIAMETERS SCREWS WHICH FRACTURED AT SOME POINT AFTER THE INITIAL SURGICAL PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT FAILED TO ACHIEVE A FUSION. THE MALIBU/DAYTONA SYSTEM HAS BEEN TESTED AND SHOWN TO BE SUBSTANTIALLY EQUIVALENT TO A PREDICATE DEVICE USING THE WORST-CASE DIAMETER SCREWS (4.5 MM) PER ASTM F1717 (STANDARD TEST METHODS FOR SPINAL IMPLANT CONSTRUCTS IN A VERTEBRECTOMY MODEL). THUS, THE 5.5 MM SCREWS USED IN THE CONSTRUCT DO NOT REPRESENT THE WORST CASE. HOWEVER, THE F1717 TESTING ONLY APPLIES TO CONSTRUCTS TESTED IN A VERTEBRECTOMY MODEL, AND NOT CONSTRUCTS USED FOR SCOLIOSIS CORRECTION. THE MOST LIKELY CAUSE OF FAILURE OF THESE TWO 5.5 MM DIAMETER SCREWS IS THE LOADING APPLIED BY SUCH A LARGE CONSTRUCT ON THESE TWO SCREWS IN COMBINATION WITH NATURAL ANATOMIC FORCES FROM THE LUMBAR SPINE. WITH THESE TWO SCREWS PLACED AT A SPINAL JUNCTION (THE THORACOLUMBAR JUNCTION AT T12/L1 WHERE LOADING IS AT IT'S HIGHEST) AND THE FAILURE OF FUSION TO OCCUR FROM THE PRIMARY SURGERY, THE LOADING APPLIED TO THESE SCREWS MOST LIKELY EXCEEDED THE LEVELS VERIFIED PER ASTM F1717 TESTING COMPLETED UNDER K122571. 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.
PATIENT UNDERWENT SPINAL SURGERY USING THE MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM. PATIENT HAD A PSEUDOARTHROSIS AT THE BOTTOM (L4/5) OF A LONG SCOLI CONSTRUCT. FUSION DID NOT OCCUR AND TWO OF THE SCREWS FAILED AND BROKE POST-OPERATIVELY. INDEX SURGERY DATE IS UNKNOWN. A REVISION SURGERY TOOK PLACE ON (B)(6) 2020, WHICH CONSISTED OF THE REMOVAL OF BI-LATERAL BROKEN SCREWS AT THE BOTTOM OF THE EXISTING SCOLI CONSTRUCT (T12). A PORTION OF THE SCREW SHAFTS WERE LEFT IN THE PEDICLE AS THE FRACTURE OCCURRED BELOW THE BONEY SURFACE. BILATERAL SCREWS WERE PLACED AT L1 / L2 / L3 (6.5 AND 7.5 MM X45 MM SCREWS). BI-LATERAL MARINER OUTRIGGER Z-RODS + BILATERAL {(1) OPEN/CLOSED 4-HOLE & (1) CLOSED/CLOSED 4-HOLE LATERAL CONNECTORS} WERE ALSO PLACED ON EACH SIDE. THE REVISION SURGERY WAS SUCCESSFUL AND THE PATIENT IS HEALING WELL, WITH NO FURTHER PLANS TO REVISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165388 | MALIBU | UNI-PLANAR DLTA SCREW,5.5 X 40 | NKB | SEASPINE INC. | 69-5540 | 10889981008666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |