X-CORE 2 TI CORE, Ø18MM 28-41MM AUTOLOCK
Report
- Report Number
- 2031966-2024-00111
- Event Type
- Injury
- Date Received
- April 16, 2024
- Date of Event
- September 20, 2023
- Report Date
- April 16, 2024
- Manufacturer
- NUVASIVE, INC.
- Product Code
- MQP
- UDI-DI
- 00887517685100
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
RELATED TO REPORT #S: 2031966-2024-00060. 2031966-2024-00061. 2031966-2024-00062. THE REPORTED EVENT WAS PRESENTED AS A LEGAL CASE WITH LIMITED INFORMATION RECEIVED, NO DEVICE RETURNED, AND NO PHOTOGRAPHS OR RADIOGRAPHIC IMAGES PROVIDED. THE PATIENT¿S BONE QUALITY WAS REPORTEDLY MODERATE. THE PATIENT WAS REPORTEDLY 180KG AND NOT FULLY COMPLIANT WITH POST-OPERATIVE ACTIVITY RESTRICTIONS. IT IS UNKNOWN WHETHER THE PATIENT EXPERIENCED A FALL OR OTHER ACCIDENT. IT SHOULD BE NOTED THAT AFTER REVISING THE POSITION OF THE VERTEBRAL BODY REPLACEMENT DEVICE AND ADDING A LATERAL PLATE FOR STABILITY, THE PATIENT ACHIEVED SUCCESSFUL FUSION. IT SHOULD ALSO BE NOTED THAT THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION FROM THE SURGEONS ASSOCIATED WITH THE PATIENT'S TREATMENT. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED; HOWEVER, REVIEW OF THE REPORTED SEQUENCE OF EVENTS AND REPORTED PATIENT DEMOGRAPHICS AND POST-OPERATIVE COMPLIANCE SUGGESTS EXCESSIVE POST OPERATIVE PHYSICAL ACTIVITY, POOR BONE QUALITY/SUBSIDENCE, INSUFFICIENT FIXATION, AND/OR EXCESSIVE LOADING ON THE FIXATION AS A RESULT OF PATIENT WEIGHT/MOVEMENT MAY BE CAUSES OR CONTRIBUTORS TO THE EVENT. MANUFACTURING RECORD REVIEW: REVIEW OF THE DEVICE HISTORY RECORD NOTES NO MATERIAL NON-CONFORMANCES, NO MANUFACTURING ERRORS, AND NO DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, OR DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL LOT UNITS MET ACCEPTANCE CRITERIA UPON RELEASE. LABELING REVIEW: "...CONTRAINDICATIONS CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO...4. PATIENTS WHO ARE UNWILLING TO RESTRICT ACTIVITIES OR FOLLOW MEDICAL ADVICE...5. PATIENTS WITH INADEQUATE BONE STOCK OR QUALITY...6. PATIENTS WITH PHYSICAL OR MEDICAL CONDITIONS THAT WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME..." "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS...POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION, NONUNION OR DELAYED UNION..." "WARNINGS, CAUTIONS AND PRECAUTIONS...THE IMPLANTATION OF SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT..." "...CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS. METALLIC INTERNAL FIXATION DEVICES CANNOT WITHSTAND THE ACTIVITY LEVELS AND/OR LOADS EQUAL TO THOSE PLACED ON NORMAL, HEALTHY BONE. THESE DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF FULL WEIGHT OR LOAD BEARING ALONE..." "...BASED ON FATIGUE TESTING RESULTS, WHEN USING THE X-CORE EXPANDABLE VBR SYSTEM AND THE X-CORE MINI CERVICAL EXPANDABLE VBR SYSTEM, THE PHYSICIAN/SURGEON SHOULD CONSIDER THE LEVELS OF IMPLANTATION, PATIENT WEIGHT, PATIENT ACTIVITY LEVEL, OTHER PATIENT CONDITIONS, ETC., WHICH MAY IMPACT ON THE PERFORMANCE OF THIS SYSTEM..." "...CAREFUL PREOPERATIVE PLANNING AND INTRAOPERATIVE SIZING TO MAXIMIZE ENDPLATE COVERAGE ARE IMPORTANT IN HELPING AVOID IMPLANT SUBSIDENCE..." "...INTERNAL FIXATION APPLIANCES ARE LOAD-SHARING DEVICES THAT HOLD BONY STRUCTURES IN ALIGNMENT UNTIL HEALING OCCURS. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND, OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT..." "...PLACE SUPPLEMENTAL FIXATION (E.G., ANTERIOR PLATE AND/OR POSTERIOR CERVICAL SCREW FIXATION SYSTEM) AT THE NECESSARY LEVELS TO REDUCE THE RISK OF IMPLANT SUBSIDENCE AND VERTEBRAL BODY FRACTURE AS WELL AS THE POTENTIAL FOR IMPLANT MIGRATION. ADDITIONAL POSTERIOR SUPPLEMENTAL FIXATION MAY BE REQUIRED IN SOME CASES FOR ADEQUATE STABILIZATION. SEE THE SUPPLEMENTAL FIXATION SYSTEM INSTRUCTIONS FOR USE AND SURGICAL TECHNIQUE FOR INSTRUCTIONS..." "...CARE SHOULD BE TAKEN TO CONFIRM THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE..." "...PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED..." "...PRE-OPERATIVE WARNINGS 1. ONLY PATIENTS THAT MEET THE CRITERIA DESCRIBED IN THE INDICATIONS SHOULD BE SELECTED. 2. PATIENT CONDITION AND/OR PREDISPOSITIONS SUCH AS THOSE ADDRESSED IN THE AFOREMENTIONED CONTRAINDICATIONS SHOULD BE AVOIDED..." "...POST-OPERATIVE WARNINGS DURING THE POSTOPERATIVE PHASE IT IS OF PARTICULAR IMPORTANCE THAT THE PHYSICIAN KEEPS THE PATIENT WELL INFORMED OF ALL PROCEDURES AND TREATMENTS. DAMAGE TO THE WEIGHT-BEARING STRUCTURES CAN GIVE RISE TO LOOSENING OF THE COMPONENTS, DISLOCATION AND MIGRATION, AS WELL AS TO OTHER COMPLICATIONS. TO ENSURE THE EARLIEST POSSIBLE DETECTION OF SUCH CATALYSTS OF DEVICE DYSFUNCTION, THE DEVICES MUST BE CHECKED PERIODICALLY POSTOPERATIVELY, USING APPROPRIATE RADIOGRAPHIC TECHNIQUES. IT IS IMPORTANT TO INSTRUCT THE PATIENT IN APPROPRIATE POSTOPERATIVE ACTIVITY RESTRICTIONS TO MINIMIZE THE RISK OF POTENTIAL VERTEBRAL BODY FRACTURE AND IMPLANT MIGRATION...." SHOULD ANY RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT A PATIENT INITIALLY UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L1 TO L3 AS THE FIRST PART OF A TWO-STAGE TREATMENT TO ADDRESS A VERTEBRAL BODY FRACTURE AT L2. APPROXIMATELY TWO MONTHS AFTER THE FIRST STAGE POSTERIOR PROCEDURE, THE SECOND STAGE OF THE TREATMENT WAS PERFORMED WITH A CORPECTOMY AND PLACEMENT OF A VERTEBRAL BODY REPLACEMENT DEVICE AT L2. PER THE REPORT, APPROXIMATELY ONE WEEK AFTER THE SECOND STAGE PROCEDURE, THE LOCK SCREWS ASSOCIATED WITH THE POSTERIOR FIXATION WERE NOTED TO BE LOOSENED AND THE VERTEBRAL BODY REPLACEMENT DEVICE WAS FOUND TO HAVE SUBSIDED; AN INITIAL REVISION SURGERY WAS PERFORMED, REPLACING THE LOOSENED LOCK SCREWS, WITH A SECOND REVISION PERFORMED NINE DAYS LATER WHERE THE VERTEBRAL BODY REPLACEMENT DEVICE WAS REPOSITIONED AND A LATERAL PLATE WAS INSTALLED FOR ADDITIONAL STABILITY. IT WAS REPORTED THAT THE PATIENT SUBSEQUENTLY ACHIEVED A FULL, SUCCESSFUL FUSION WITH NO FURTHER COMPLICATIONS; THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION FROM THE SURGEONS INVOLVED IN THE PATIENT'S TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1868096 | X-CORE 2 TI CORE, Ø18MM 28-41MM AUTOLOCK | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | MQP | NUVASIVE, INC. | 7180041AP2 | ML03180 | 00887517685100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization | 2X RELINE MAS ROD| 4X UNSPECIFIED TRAVERSE SCREWS| RELINE MAS SCREW+LS| TRAVERSE PLATE, SIZE 60 FIXED,| X-CORE 2 TI ENDCAP| X-CORE 2 TI LOCK SCREW, ENDCAP |