PRODISC-C IMPLANT LARGE 6MM-STERILE
Report
- Report Number
- 2530088-2013-00481
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- March 4, 2013
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MJO
- PMA / PMN Number
- P070001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTED DATE OF IMPLANT WAS 2009 (DATE UNKNOWN). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ALL DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED THE PART MET SPECIFICATIONS. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THERE IS NOT ENOUGH INFORMATION AVAILABLE FOR THIS COMPLAINT TO DETERMINE THE CAUSE OF IMPLANT MIGRATION. THE ENDPLATE KEEL IS THE IMPLANT¿S MAIN SOURCE FOR PRIMARY FIXATION. EXPULSION TESTING UNDER A WORST CASE SCENARIO FOUND THE FIXATION PROVIDED BY THE IMPLANT KEEL TO BE MORE THAN SUFFICIENT TO WITHSTAND NORMAL PHYSIOLOGIC SHEAR LOADS IN THE CERVICAL SPINE. THE DEVICE IS INTENDED TO RESTORE DISC HEIGHT AND MAINTAIN MOTION OF THE SEGMENT AS DOCUMENTED. THE BREAKDOWN OF THE ADJACENT DISC CAN BE CAUSED BY MULTIPLE FACTORS INCLUDING THE MIGRATION OF THE DEVICE AFFECTING THE CENTER OF ROTATION OF THE DISC OR NATURAL PROGRESSION OF THE DISEASE STATE AT THE TREATED LEVEL WHICH IS NOT A FAILURE OF THE DEVICE. JOURNAL REVIEW: A SEARCH ON PUB-MED USING SEARCH TERM ¿PRODISC-C MIGRATION¿ IDENTIFIED THE FOLLOWING REFERENCES: PRODISC-C AND ACDF AS SURGICAL TREATMENT FOR SINGLE LEVEL CERVICAL SYMPTOMATIC DEGENERATIVE DISC DISEASE: FIVE-YEAR RESULTS OF AN FDA STUDY. ZIGLER JE, DELAMARTER R, MURREY D, SPIVAK J, JANSSEN M. SPINE (PHILA PA 1976). 2013 FEB 1; 38(3): 203-9. VERTEBRAL BODY SPLIT FRACTURE AFTER A SINGLE-LEVEL CERVICAL TOTAL DISC REPLACEMENT. TU TH, WU JC, FAY LY, KO CC, HUANG WC, CHENG H. J NEUROSURG SPINE. 2012 MAR;16(3):231-5. DOI: 10.3171/2011.11.SPINE11210. EPUB 2011 DEC 16. [PRODISC-C MOBILE REPLACEMENT OF AN INTERVERTEBRAL DISC. A PROSPECTIVE MONO-CENTRIC TWO-YEAR STUDY]. STULÍK J, KRYL J, SEBESTA P, VYSKOCIL T, KRBEC M, TRC T. ACTA CHIR ORTHOP TRAUMATOL CECH. 2008 AUG;75(4):253-61. CZECH. NONE OF THESE REFERENCES REPORT PRODISC-C MIGRATIONS THAT REQUIRED REVISION SURGERY. THE 5 YEAR RESULTS OF THE PRODISC-C IDE STUDY REPORTS NO IMPLANT MIGRATION WITH PRODISC-C. BASED ON THE MECHANICAL TESTING, THE CURRENT DESIGN OF THE PRODISC-C IMPLANT IS SUFFICIENT TO PREVENT IMPLANT MIGRATION EVEN UNDER SHEAR LOADING IN EXCESS OF THOSE ROUTINELY SEEN IN THE CERVICAL SPINE. THE CAUSE FOR MIGRATION IN THIS CASE IS NOT KNOWN. LIKELY CAUSES FOR IMPLANT MIGRATION INCLUDE IMPROPER SURGICAL TECHNIQUE, PLACEMENT, TRAUMA AND/OR PATIENT SELECTION. DEVICE WAS RETURNED TO HOSPITAL FOR SPECIAL SURGERY FOR THIRD PARTY EVALUATION ON AN UNKNOWN DATE. PLACEHOLDER.
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A THIRD PARTY EVALUATION WAS CONDUCTED BY THE HOSPITAL FOR SPECIAL SURGERY. THE SUPERIOR SURFACE OF THE SUPERIOR ENDPLATE DISPLAYS SEVERE DAMAGE RESULTING IN REMOVAL OF THE PLASMA SPRAYED COATING AND DEFORMATION TO THE KEEL CONSISTENT WITH SURGICAL TOOL MARKS. NO ADHERENT BONE WAS OBSERVED ON THE SUPERIOR SURFACE. THE INFERIOR SURFACE OF THE ENDPLATE SHOWS SEVERE DEFORMATION TO THE ANTERIOR REGION OF THE ENDPLATE. BURNISHING WAS ALSO OBSERVED ON THE ANTERIOR REGION OF THE ENDPLATE. THE ARTICULAR SURFACE OF THE ENDPLATE DISPLAYS MODERATE PITTING AND SCRATCHING ACROSS THE ENTIRE SURFACE. THESE FEATURES ARE CONSISTENT WITH HANDLING AND/OR NORMAL WEAR THAT IS COMMONLY OBSERVED IN METAL-ON-POLYETHYLENE ARTICULATIONS IN TOTAL JOINT REPLACEMENTS. THE POLYETHYLENE INLAY WAS RECEIVED ATTACHED TO THE INFERIOR ENDPLATE. SEVERE DEFORMATION WAS SEEN ON THE ANTERIOR ASPECT OF THE SUPERIOR POLYETHYLENE SURFACE. THE POSTERIOR REGION OF THE INLAY DISPLAYS DEFORMATION AND HIGHLY BURNISHED SURFACE. THE ARTICULAR SURFACE OF THE INLAY SHOWS MODERATE PITTING AND SCRATCHING. THESE FEATURES ARE CONSISTENT WITH HANDLING AND/OR NORMAL WEAR THAT IS COMMONLY OBSERVED IN METAL-ON-POLYETHYLENE ARTICULATIONS IN TOTAL JOINT REPLACEMENTS. THE ARTICULAR SURFACE OF THE INLAY ALSO HAS ONE EMBEDDED METALLIC PARTICLE. THE SUPERIOR SURFACE OF THE INFERIOR INLAY DISPLAYS DEFORMATION IN THE ANTERIOR REGION ON BOTH LATERAL FLANGES. NO ADHERENT BONE WAS VISIBLE ON THE INFERIOR SURFACE OF THE ENDPLATE. SEVERE DAMAGE RESULTING IN REMOVAL OF THE TITANIUM PLASMA SPRAYED COATING IS OBSERVED ON THE INFERIOR SURFACE CONSISTENT WITH REMOVAL TECHNIQUE. BASED ON THE HOSPITAL FOR SPECIAL SURGERY EVALUATION, DEPUY SYNTHES SPINE PRODUCT DEVELOPMENT STATED THERE IS NO EVIDENCE OF DEVICE FAILURE OR MALFUNCTION THAT WARRANTS FURTHER ACTIONS AND NO NEW RISKS CAN BE IDENTIFIED. THE IMPLANT COMPONENTS SHOW SIGNS OF NORMAL WEAR COMMONLY OBSERVED IN METAL-ON-PE ARTICULATIONS IN TOTAL JOINT REPLACEMENTS INCLUDING DEFORMATION AND A HIGH BURNISHED FINISH ON THE POSTERIOR SURFACE OF THE INLAY. THERE IS SIGNIFICANT DAMAGE TO THE SUPERIOR AND INFERIOR COATED SURFACES, THE ENDPLATES, AND THE POLYETHYLENE CORE CONSISTENT WITH SURGICAL REMOVAL OF THE DEVICE. THERE IS EMBEDDED METAL PARTICULATE IN THE POLYETHYLENE CORE BUT IT CANNOT BE DETERMINED IF THE PARTICULATE IS THE RESULT OF THE SEVERE DAMAGE DURING REMOVAL OR IF IT WAS A RESULT OF THE ORIGINAL SURGERY. INCREASED WEAR RATES AS A RESULT OF THIRD PARTY DEBRIS HAS BEEN REVIEWED. NO NEW RISKS, USER NEEDS, OR UPDATES TO THE PRODUCT DEVELOPMENT EVALUATION FOR THE COMPLAINT HAVE BEEN IDENTIFIED AS A RESULT OF THE CONDITION OF THE DEVICE. AS SUCH NO FURTHER ACTION IS REQUIRED.
PATIENT WAS IMPLANTED WITH PRODISC-C AT C6-C7 ON AN UNKNOWN DATE IN 2009. ON AN UNKNOWN DATE IN (B)(6) 2013, THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF PAIN ADJACENT TO THE PRODISC-C AREA. EXAMINATION, X-RAY AND MRI IMAGES INDICATED AN ADJACENT LEVEL DISC DISEASE AT C5-C6 AND ALSO REVEALED THE PRODISC-C HAD MIGRATED ANTERIORLY. THE SURGEON RETURNED THE PATIENT TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED THE PRODISC-C AND THE PATIENT WAS REVISED TO AN ACDF FUSION AT LEVELS C5-C6 AND C6-C7. REPORTEDLY THE PATIENT IS RECOVERING WELL.
THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134594 | PRODISC-C IMPLANT LARGE 6MM-STERILE | MJO | SYNTHES BRANDYWINE | 6417400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |