BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPEDIUM POSTERIOR

    MDR report key: 20586730 · Received November 1, 2024

    Report

    Report Number
    1526439-2024-02796
    Event Type
    Injury
    Date Received
    November 1, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01)GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING: EXPEDIUM ANTERIOR STUDY ¿ UNY. EXACT QUANTITIES OF PRODUCTS CANNOT BE ACCURATELY DETERMINED AS THE REPORT INDICATES A PATIENT MAY EXPERIENCE MORE THAN ONE ADVERSE EVENT. ADDITIONALLY SOME ADVERSE EVENTS CAN BE ONGOING OR RECURRENT THAT ARE NOTED AT LONG TERM FOLLOW UP. AT COHORT IMPLANTED WITH THE EXPEDIUM ANTERIOR SPINE SYSTEM. ADVERSE EVENTS OF INTEREST AT INTRA-OPERATIVE: QTY 1 ACUTE BLOOD LOSS ANEMIA, QTY 5 DURAL TEAR, QTY 1 PLEURAL TEAR, QTY 1 SPINAL CORD SIGNAL CHANGE. ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY 2 ABSCESS/INFECTION, QTY 4 ACUTE BLOOD LOSS ANEMIA, QTY 1 ANEMIA, QTY 2 INFECTION, QTY 1 NEUROGENIC BLADDER, QTY 1 PARAPLEGIA, QTY 1 PNEUMOTHORAX. ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY 1 ABDOMINAL BLOATING, QTY 1 ALTERED MENTATION, QTY 2 BACK PAIN, QTY 2 CSF LEAK, QTY 1 HEADACHE, QTY 2 INFECTION, QTY 1 VERTEBRAL BODY FRACTURE, QTY 1 WOUND COMPLICATION, QTY 1 WOUND INFECTION. ADVERSE EVENTS OF INTEREST AT 3 MONTHS POSTOPERATIVE: QTY 1 BACK PAIN. ADVERSE EVENTS OF INTEREST AT 6 MONTHS POSTOPERATIVE: QTY 1 BACK PAIN. ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY 1 INFECTION, QTY 1 LOWER EXTREMITY PARESTHESIA, QTY 1 RECURRENT TUMOR, QTY 1 ROD FRACTURE. ADVERSE EVENTS OF INTEREST AT 24 MONTHS POSTOPERATIVE: QTY 1 BACK PAIN, QTY 1 CSF (LED TO REOPERATION), QTY 2 DURAL TEAR (LED TO REOPERATION), QTY 1 FOOT DROP, QTY 2 HEADACHE (FROM ADDITIONAL REOPERATION), QTY 1 LOW BACK PAIN, QTY 1 PLEURAL EFFUSION, QTY 1 RECURRENCE TUMOR, QTY 2 RECURRENT TUMOR, QTY 1 SENSORY AND MOTOR ABNORMALITIES, QTY 1 WOUND COMPLICATION (FROM ADDITIONAL REOPERATION). SERIOUS ADVERSE EVENTS OF INTEREST AT INTRA-OPERATIVE: QTY 1 ACUTE BLOOD LOSS ANEMIA, QTY 3 DURAL TEAR, QTY 1 PLEURAL TEAR, QTY 1 SPINAL CORD SIGNAL CHANGE (LED TO REOPERATION). SERIOUS ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY 1 NEUROGENIC BLADDER, QTY 1 PNEUMOTHORAX. SERIOUS ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY 1 CSF LEAK, QTY 1 HEADACHE, QTY 1 INFECTION, QTY 1 WOUND INFECTION. SERIOUS ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY 1 ROD FRACTURE (TREATED WITH REVISION). SERIOUS ADVERSE EVENTS OF INTEREST AT 24 MONTHS POSTOPERATIVE: QTY 1 CSF (LED TO REOPERATION), QTY 2 DURAL TEAR (LED TO REOPERATION), QTY 1 FOOT DROP, QTY 2 HEADACHE (FROM ADDITIONAL REOPERATION), QTY 1 LOW BACK PAIN, QTY 1 PLEURAL EFFUSION, QTY 1 RECURRENCE TUMOR (LED TO REOPERATION), QTY 1 RECURRENT TUMOR (TREATED WITH REVISION), QTY 1 WOUND COMPLICATION (FROM ADDITIONAL REOPERATION). AT COHORT IMPLANTED WITH THE EXPEDIUM POSTERIOR SPINE SYSTEM: ADVERSE EVENTS OF INTEREST AT INTRA-OPERATIVE: QTY 1 CSF LEAK. ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY 3 ACUTE BLOOD LOSS ANEMIA, QTY 1 ANEMIA, QTY 1 CONTINUED PARALYSIS, QTY 1 LE SENSORY AND MOTOR ABNORMALITIES. ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY 1 BACK PAIN, QTY 1 LEG PAIN, QTY 1 PLEURAL EFFUSION, QTY 1 WOUND COMPLICATION. ADVERSE EVENTS OF INTEREST AT 3 MONTHS POSTOPERATIVE: QTY 1 BACK PAIN, QTY 1 FOOT DROP, QTY 1 LOWER EXTREMITY PARESTHESIA. ADVERSE EVENTS OF INTEREST AT 6 MONTHS POSTOPERATIVE: QTY 1 LOWER EXTREMITY MOTOR AND SENSOR ABNORMALITIES. ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY 1 ACUTE BLOOD LOSS ANEMIA (ADDITIONAL REOPERATION), QTY 1 BACK PAIN, QTY 1 HARDWARE FAILURE (TREATED WITH REVISION), QTY 2 LEG PAIN, QTY 1 SI JOINT EDEMA. ADVERSE EVENTS OF INTEREST AT 24 MONTHS POSTOPERATIVE: QTY 1 FALL, QTY 1 LOWER EXTREMITY PARESTHESIA. SERIOUS ADVERSE EVENTS OF INTEREST AT INTRA-OPERATIVE: QTY 1 ACUTE BLOOD LOSS ANEMIA. SERIOUS ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY 1 LE SENSORY AND MOTOR ABNORMALITIES. SERIOUS ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY 1 PLEURAL EFFUSION. SERIOUS ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY 1 ACUTE BLOOD LOSS ANEMIA (ADDITIONAL REOPERATION), QTY 1 HARDWARE FAILURE (TREATED WITH REVISION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189359 UNK - CONSTRUCTS: EXPEDIUM POSTERIOR THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention