BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 12089198 · Received June 29, 2021

    Report

    Report Number
    3004024955-2021-00016
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    January 1, 2017
    Report Date
    October 29, 2021
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE 'MANAGEMENT OF THORACIC DISC HERNIATIONS VIA POSTERIOR UNILATERAL MODIFIED TRANSFACET PEDICLE¿SPARING DECOMPRESSION WITH SEGMENTAL INSTRUMENTATION AND INTERBODY FUSION' IN GLOBAL SPINE JOURNAL, VOLUME 7 (506-513) 2017 WAS REVIEWED. BETWEEN (B)(6) 2007 AND (B)(6) 2011, FIFTY-ONE PATIENTS WITH SYMPTOMATIC THORACIC DISC HERNIATIONS (TDH) WERE TREATED. ALL PATIENTS UNDERWENT OPEN OR MINIMALLY INVASIVE MODIFIED TRANSFACET PEDICLE¿SPARING DISCECTOMY AND SEGMENTAL INSTRUMENTATION WITH INTERBODY FUSION, PERFORMED BY FOUR DIFFERENT SURGEONS. STRYKER PRODUCTS USED DURING THE STUDY ARE: DENALI, UNKNOWN XIA, UNKNOWN PEEK CAGE AMONG WITH PRODUCTS FROM OTHER MANUFACTURERS. CATALOG AND LOT NUMBERS WERE NOT PROVIDED. NO STRYKER PRODUCT FAILURE WAS REPORTED VIA THIS COMPLAINT. THIS COMPLAINT ADDRESSED A MIGRATED BONE FRAGMENT INTO THE T10 TO T11 FORAMEN REPORTED FOR ONE PATIENT. THIS WAS TREATED CONSERVATIVELY WITHOUT NEUROLOGICAL INJURY. THE ETIOLOGY OF THE BONE FRAGMENT IS UNKNOWN. THE AUTHOR OF THE ARTICLE CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE. THERE IS NO STRYKER DEVICE FAILURE REPORTED VIA THIS COMPLAINT. THE ARTICLE CONCLUDES THAT THE PATIENTS HAD IMPROVED PAIN CONTROL AS WELL AS REMAINED STABLE OR IMPROVED FUNCTIONALLY BASED ON DATA PROVIDED BY VAS, AIS, AND NURICK SCORES.

    Description of Event or Problem · 0

    THE ARTICLE 'MANAGEMENT OF THORACIC DISC HERNIATIONS VIA POSTERIOR UNILATERAL MODIFIED TRANSFACET PEDICLE¿SPARING DECOMPRESSION WITH SEGMENTAL INSTRUMENTATION AND INTERBODY FUSION' IN GLOBAL SPINE JOURNAL, VOLUME 7 (506-513) 2017, WAS REVIEWED. BETWEEN (B)(6) 2007 AND (B)(6) 2011, FIFTY-ONE PATIENTS WITH SYMPTOMATIC THORACIC DISC HERNIATIONS (TDH) WERE TREATED VIA AN OPEN OR MINIMALLY INVASIVE, MODIFIED TRANSFACET PEDICLE¿SPARING DECOMPRESSION AND FUSION TECHNIQUE. PATIENT AGE WAS AN AVERAGE OF 60 YEARS OLD (RANGE 39 TO 85 YEARS); 31 PATIENTS WERE FEMALE AND 20 WERE MALE. SIXTEEN PATIENTS HAD THORACIC MYELOPATHY WITH SIGNAL CORD CHANGES PRESENT ON MRI IMAGING. EIGHTEEN PATIENTS COMPLAINED OF RADICULAR SYMPTOMS. EIGHT PATIENTS HAD MYELOPATHY AS WELL AS RADICULOPATHY. TEN PATIENTS HAD INTRACTABLE BACK PAIN REFERABLE TO THE THORACIC DISC BASED ON CLINICAL EVALUATION. TWENTY-ONE PATIENTS HAD TDH AT THE APEX OF THE THORACIC CURVE. SEGMENTAL FIXATION WAS PERFORMED USING ONE OF THREE SYSTEMS; DENALI, XIA, OR A NON-STRYKER PEDICLE SCREW SYSTEM. INTERBODY ARTHRODESIS WAS ACCOMPLISHED WITH STRYKER PEEK CAGE OR WITH A NON-STRYKER MACHINED FREEZE DRIED ALLOGRAFT INTERBODY FUSION CAGE. CAGES WERE PACKED WITH LOCAL MORSELIZED BONE GRAFT, ALLOGRAFT CANCELLOUS CHIPS AND/OR BONE MORPHOGENIC PROTEIN (BOTH NON-STRYKER DEVICES). FORTY-SEVEN PATIENTS SHOWED NO SIGNS OF INSTRUMENT MIGRATION OR FAILURE AND WENT ON TO ACHIEVE RADIOGRAPHIC FUSION. THERE WAS NO PERMANENT POSTOPERATIVE NERVE INJURY, PARALYSIS, OR PNEUMOTHORAX. THE AUTHORS NOTE THAT THE COMPLICATIONS IDENTIFIED DURING IN THIS SERIES ARE POTENTIAL COMPLICATIONS OF ANY SPINAL SURGERY, INCLUDING POSTOPERATIVE HEMATOMA, INFECTION, POSTOPERATIVE RESPIRATORY FAILURE, AND IMPLANT OR ALLOGRAFT MALPOSITION. ONE PATIENT HAD A MIGRATED BONE FRAGMENT INTO THE T10 TO T11 FORAMEN. THIS WAS TREATED CONSERVATIVELY WITHOUT NEUROLOGICAL INJURY. THE ETIOLOGY OF THE BONE FRAGMENT IS UNKNOWN. ONE PATIENT HAD A LONG SCREW PLACED AT T9 DURING FUSION. ONE YEAR AFTER SURGERY, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PAINFUL HARDWARE. DURING ATTEMPTS TO REMOVE THE T9 SCREW, PULSATILE BLEEDING WAS ENCOUNTERED AND THE SCREW WAS QUICKLY REPLACED TO TAMPONADE THE BLEEDING. POSTOPERATIVELY, THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT, AND VASCULAR SURGERY WAS CONSULTED. VASCULAR SURGERY RECOMMENDED OBSERVATION FOR SEVERAL DAYS. DURING HIS HOSPITALIZATION, THERE WAS NO VASCULAR COMPLICATION INCLUDING NO ARTERIAL THROMBUS AND NO DECREASE IN HEMOGLOBIN. THE PATIENT WAS DISCHARGED AND HAD A SUCCESSFUL RECOVERY WITH NO VASCULAR COMPLICATIONS OR NEUROLOGICAL DEFICIT.

    Additional Manufacturer Narrative · 1

    DEVICE LOCATION UNKNOWN.

    Description of Event or Problem · 1

    THE ARTICLE 'MANAGEMENT OF THORACIC DISC HERNIATIONS VIA POSTERIOR UNILATERAL MODIFIED TRANSFACET PEDICLE¿SPARING DECOMPRESSION WITH SEGMENTAL INSTRUMENTATION AND INTERBODY FUSION' IN GLOBAL SPINE JOURNAL, VOLUME 7 (506-513) 2017, WAS REVIEWED. BETWEEN (B)(6) 2007 AND (B)(6) 2011, FIFTY-ONE PATIENTS WITH SYMPTOMATIC THORACIC DISC HERNIATIONS (TDH) WERE TREATED VIA AN OPEN OR MINIMALLY INVASIVE, MODIFIED TRANSFACET PEDICLE¿SPARING DECOMPRESSION AND FUSION TECHNIQUE. PATIENT AGE WAS AN AVERAGE OF 60 YEARS OLD (RANGE 39 TO 85 YEARS); 31 PATIENTS WERE FEMALE AND 20 WERE MALE. SIXTEEN PATIENTS HAD THORACIC MYELOPATHY WITH SIGNAL CORD CHANGES PRESENT ON MRI IMAGING. EIGHTEEN PATIENTS COMPLAINED OF RADICULAR SYMPTOMS. EIGHT PATIENTS HAD MYELOPATHY AS WELL AS RADICULOPATHY. TEN PATIENTS HAD INTRACTABLE BACK PAIN REFERABLE TO THE THORACIC DISC BASED ON CLINICAL EVALUATION. TWENTY-ONE PATIENTS HAD TDH AT THE APEX OF THE THORACIC CURVE. SEGMENTAL FIXATION WAS PERFORMED USING ONE OF THREE SYSTEMS; DENALI, XIA, OR A NON-STRYKER PEDICLE SCREW SYSTEM. INTERBODY ARTHRODESIS WAS ACCOMPLISHED WITH STRYKER PEEK CAGE OR WITH A NON-STRYKER MACHINED FREEZE DRIED ALLOGRAFT INTERBODY FUSION CAGE. CAGES WERE PACKED WITH LOCAL MORSELIZED BONE GRAFT, ALLOGRAFT CANCELLOUS CHIPS AND/OR BONE MORPHOGENIC PROTEIN (BOTH NON-STRYKER DEVICES). FORTY-SEVEN PATIENTS SHOWED NO SIGNS OF INSTRUMENT MIGRATION OR FAILURE AND WENT ON TO ACHIEVE RADIOGRAPHIC FUSION. THERE WAS NO PERMANENT POSTOPERATIVE NERVE INJURY, PARALYSIS, OR PNEUMOTHORAX. THE AUTHORS NOTE THAT THE COMPLICATIONS IDENTIFIED DURING IN THIS SERIES ARE POTENTIAL COMPLICATIONS OF ANY SPINAL SURGERY, INCLUDING POSTOPERATIVE HEMATOMA, INFECTION, POSTOPERATIVE RESPIRATORY FAILURE, AND IMPLANT OR ALLOGRAFT MALPOSITION. ONE PATIENT HAD A MIGRATED BONE FRAGMENT INTO THE T10 TO T11 FORAMEN. THIS WAS TREATED CONSERVATIVELY WITHOUT NEUROLOGICAL INJURY. THE ETIOLOGY OF THE BONE FRAGMENT IS UNKNOWN. ONE PATIENT HAD A LONG SCREW PLACED AT T9 DURING FUSION. ONE YEAR AFTER SURGERY, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PAINFUL HARDWARE. DURING ATTEMPTS TO REMOVE THE T9 SCREW, PULSATILE BLEEDING WAS ENCOUNTERED AND THE SCREW WAS QUICKLY REPLACED TO TAMPONADE THE BLEEDING. POSTOPERATIVELY, THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT, AND VASCULAR SURGERY WAS CONSULTED. VASCULAR SURGERY RECOMMENDED OBSERVATION FOR SEVERAL DAYS. DURING HIS HOSPITALIZATION, THERE WAS NO VASCULAR COMPLICATION INCLUDING NO ARTERIAL THROMBUS AND NO DECREASE IN HEMOGLOBIN. THE PATIENT WAS DISCHARGED AND HAD A SUCCESSFUL RECOVERY WITH NO VASCULAR COMPLICATIONS OR NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983193 UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention