BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN XIA SCREW

    MDR report key: 12035835 · Received June 21, 2021

    Report

    Report Number
    0009617544-2021-00108
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    August 25, 2012
    Report Date
    October 7, 2021
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    'POSTERIOR INSTRUMENTATION, ANTERIOR COLUMN RECONSTRUCTION WITH SINGLE POSTERIOR APPROACH FOR TREATMENT OF PYOGENIC OSTEOMYELITIS OF THORACIC AND LUMBAR SPINE' PUBLISHED IN EUROPEAN SPINE JOURNAL, VOLUME 22 (533-641) 2013. LIMITED INFORMATION REGARDING THE EVENT WAS MADE AVAILABLE TO STRYKER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED AND THE FINAL OUTCOME IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE REVIEWED WITHOUT EITHER THE DEVICE OR A VALID LOT NUMBER. THE ARTICLE NOTED THAT PATIENT 8 DID NOT FUSE. PER XIA SURGICAL TECHNIQUE: DELAYED UNION OR NONUNION: INTERNAL FIXATION APPLIANCES ARE LOAD SHARING DEVICES WHICH ARE USED TO OBTAIN ALIGNMENT UNTIL NORMAL HEALING OCCURS . IN THE EVENT THAT HEALING IS DELAYED, DOES NOT OCCUR, OR FAILURE TO IMMOBILIZE THE DELAYED/NONUNION RESULTS, THE IMPLANT WILL BE SUBJECT TO EXCESSIVE AND REPEATED STRESSES WHICH CAN EVENTUALLY CAUSE LOOSENING, BENDING OR FATIGUE FRACTURE . THE DEGREE OR SUCCESS OF UNION, LOADS PRODUCED BY WEIGHT BEARING, AND ACTIVITY LEVELS WILL, AMONG OTHER CONDITIONS, DICTATE THE LONGEVITY OF THE IMPLANT . IF A NONUNION DEVELOPS OR IF THE IMPLANTS LOOSEN, BEND OR BREAK, THE DEVICE(S) SHOULD BE REVISED OR REMOVED IMMEDIATELY BEFORE SERIOUS INJURY OCCURS. THE ARTICLE NOTED THAT THE PATIENT 8 WAS DIAGNOSED AND TREATED FOR A GASTRIC CANCER. PER XIA SURGICAL TECHNIQUE: CIRCUMSTANCES LISTED BELOW MAY REDUCE THE CHANCES OF A SUCCESSFUL OUTCOME: MEDICAL OR SURGICAL CONDITION WHICH WOULD PRECLUDE THE POTENTIAL BENEFIT OF SPINAL IMPLANT SURGERY, SUCH AS THE PRESENCE OF TUMORS, CONGENITAL ABNORMALITIES, ELEVATION OF SEDIMENTATION RATE UNEXPLAINED BY OTHER DISEASES, ELEVATION OF WHITE BLOOD CELL COUNT (WBC), OR MARKED LEFT SHIFT IN THE WBC DIFFERENTIAL COUNT . THE ROOT CAUSE OF THE SCREWS LOOSENING CANNOT BE DETERMINED CONCLUSIVELY FROM THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE 'POSTERIOR INSTRUMENTATION, ANTERIOR COLUMN RECONSTRUCTION WITH SINGLE POSTERIOR APPROACH FOR TREATMENT OF PYOGENIC OSTEOMYELITIS OF THORACIC AND LUMBAR SPINE' IN EUROPEAN SPINE JOURNAL, VOLUME 22 (533-641) 2013, WAS REVIEWED. THE RECORDS OF PATIENTS, TREATED FOR PYROGENIC OSTEOMYELITIS OF THORACIC AND LUMBAR SPINE BETWEEN JANUARY 2006 AND JUNE 2011 WERE REVIEWED. CAUSATIVE BACTERIA WERE FOUND IN ALL BUT TWO CASES: EIGHT CASES OF STAPHYLOCOCCUS AUREUS, TWO CASES OF COAGULASE NEGATIVE STAPHYLOCOCCI, TWO CASES OF PROPIONIBACTERIUM ACNES, ONE CASE OF BETA-HEMOLYTIC STREPTOCOCCUS GROUP G, ONE CASE OF SERRATIA MARCESCENS, ONE CASE OF STREPTOCOCCUS C. INFECTION COMPLETELY RESOLVED AFTER OPERATIVE AND ANTIBIOTIC INTRAVENOUS AND PER-ORAL THERAPY IN ALL 17 PATIENTS. OUT OF 108 PATIENTS, 17 PATIENTS UNDERWENT POSTERIOR INSTRUMENTATION AND ANTERIOR COLUMN RECONSTRUCTION WITH POSTERIOR APPROACH ONLY. THE AVERAGE AGE OF PATIENTS WAS 66 YEARS (37¿28 YEARS); THERE WERE 8 FEMALE AND 9 MALE PATIENTS. PATIENTS WERE IMPLANTED WITH XIA PEDICLE SCREWS AND SIX PATIENTS WERE IMPLANTED WITH VLIFT VERTEBRAL BODY REPLACEMENTS. SOLID BONY FUSION WAS ACHIEVED IN 15 OUT OF 17 PATIENTS BETWEEN THREE AND SIXTEEN MONTHS POSTOPERATIVELY. A SINGLE DEVICE-RELATED COMPLICATION WAS NOTED. ONE PATIENT (PATIENT 8) PRESENTED WITH VERTEBRAL OSTEOMYELITIS AND HAD SEVERE OSTEOPOROSIS. THEY WERE IMPLANTED WITH XIA AND VLIFT VERTEBRAL BODY REPLACEMENT. ALTHOUGH NO SOLID BONY FUSION WAS ACHIEVED, THE PATIENT WAS SATISFIED WITH THE PROCEDURE. TWENTY-EIGHT MONTHS AFTER OPERATION THEY PRESENTED AT OUTPATIENT CLINIC WITH MECHANICAL BACK PAIN. RADIOGRAPHY SHOWED PULLOUT OF DISTAL PEDICULAR SCREWS. THEY WERE A CANDIDATE FOR REOPERATION BUT WERE DIAGNOSED WITH GASTRIC CANCER AND HOSPITALIZED FOR TREATMENT BEFORE REVISION COULD OCCUR; FINAL OUTCOME IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    LOCATION OF DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE ARTICLE 'POSTERIOR INSTRUMENTATION, ANTERIOR COLUMN RECONSTRUCTION WITH SINGLE POSTERIOR APPROACH FOR TREATMENT OF PYOGENIC OSTEOMYELITIS OF THORACIC AND LUMBAR SPINE' IN EUROPEAN SPINE JOURNAL, VOLUME 22 (533-641) 2013, WAS REVIEWED. THE RECORDS OF PATIENTS, TREATED FOR PYROGENIC OSTEOMYELITIS OF THORACIC AND LUMBAR SPINE BETWEEN JANUARY 2006 AND JUNE 2011 WERE REVIEWED. CAUSATIVE BACTERIA WERE FOUND IN ALL BUT TWO CASES: EIGHT CASES OF STAPHYLOCOCCUS AUREUS, TWO CASES OF COAGULASE NEGATIVE STAPHYLOCOCCI, TWO CASES OF PROPIONIBACTERIUM ACNES, ONE CASE OF BETA-HEMOLYTIC STREPTOCOCCUS GROUP G, ONE CASE OF SERRATIA MARCESCENS, ONE CASE OF STREPTOCOCCUS C. INFECTION COMPLETELY RESOLVED AFTER OPERATIVE AND ANTIBIOTIC INTRAVENOUS AND PER-ORAL THERAPY IN ALL 17 PATIENTS. OUT OF 108 PATIENTS, 17 PATIENTS UNDERWENT POSTERIOR INSTRUMENTATION AND ANTERIOR COLUMN RECONSTRUCTION WITH POSTERIOR APPROACH ONLY. THE AVERAGE AGE OF PATIENTS WAS 66 YEARS (37¿28 YEARS); THERE WERE 8 FEMALE AND 9 MALE PATIENTS. PATIENTS WERE IMPLANTED WITH XIA PEDICLE SCREWS AND SIX PATIENTS WERE IMPLANTED WITH VLIFT VERTEBRAL BODY REPLACEMENTS. SOLID BONY FUSION WAS ACHIEVED IN 15 OUT OF 17 PATIENTS BETWEEN THREE AND SIXTEEN MONTHS POSTOPERATIVELY. A SINGLE DEVICE-RELATED COMPLICATION WAS NOTED. ONE PATIENT (PATIENT 8) PRESENTED WITH VERTEBRAL OSTEOMYELITIS AT AGE (B)(6) AND HAD SEVERE OSTEOPOROSIS. THEY WERE IMPLANTED WITH XIA AND VLIFT VERTEBRAL BODY REPLACEMENT. ALTHOUGH NO SOLID BONY FUSION WAS ACHIEVED, THE PATIENT WAS SATISFIED WITH THE PROCEDURE. 28 MONTHS AFTER OPERATION THEY PRESENTED AT OUTPATIENT CLINIC WITH MECHANICAL BACK PAIN. RADIOGRAPHY SHOWED PULLOUT OF DISTAL PEDICULAR SCREWS. THEY WERE A CANDIDATE FOR REOPERATION BUT WERE DIAGNOSED WITH GASTRIC CANCER AND HOSPITALIZED FOR TREATMENT BEFORE REVISION COULD OCCUR; FINAL OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931397 UNKNOWN XIA SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other