BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: EXPEDIUM: ANTERIOR

    MDR report key: 19808212 · Received July 23, 2024

    Report

    Report Number
    1526439-2024-01913
    Event Type
    Injury
    Date Received
    July 23, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: EXPEDIUM: ANTERIOR/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. H6 COMPONENT CODE: G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) USED TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE ADVERSE EVENTS PREVIOUSLY SENT ON (B)(6)2024 WERE ONLY FOR EXPEDIUM ANTERIOR, BUT THEY HAVE NOW BEEN CATEGORIZED INTO EXPEDIUM ANTERIOR AND EXPEDIUM POSTERIOR. DRRA FORM HAS BEEN UPDATED AND WILL SUPERSEDE THE EARLIER ONE SENT IN (B)(6). UPDATED EVENT DESCRIPTION BASED ON THE ADDITIONAL INFORMATION PROVIDED: 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 (B)(4) ACUTE BLOOD LOSS ANEMIA, QTY (B)(4) DURAL TEAR, QTY 1(B)(4) PLEURAL TEAR, QTY (B)(4) SPINAL CORD SIGNAL CHANGE. ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY (B)(4) ABSCESS/INFECTION, QTY (B)(4) ACUTE BLOOD LOSS ANEMIA, QTY (B)(4) ANEMIA, QTY (B)(4) INFECTION, QTY 1(B)(4) NEUROGENIC BLADDER, QTY (B)(4) PARAPLEGIA, QTY (B)(4) PNEUMOTHORAX. ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY (B)(4) ABDOMINAL BLOATING, QTY (B)(4) ALTERED MENTATION, QTY (B)(4) BACK PAIN, QTY (B)(4) CSF LEAK, QTY (B)(4) HEADACHE, QTY 2(B)(4) INFECTION, QTY (B)(4) VERTEBRAL BODY FRACTURE, QTY (B)(4) WOUND COMPLICATION, QTY (B)(4) WOUND INFECTION. ADVERSE EVENTS OF INTEREST AT 3 MONTHS POSTOPERATIVE: QTY (B)(4) BACK PAIN. ADVERSE EVENTS OF INTEREST AT 6 MONTHS POSTOPERATIVE: QTY (B)(4) BACK PAIN. ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY (B)(4) INFECTION, QTY (B)(4) LOWER EXTREMITY PARESTHESIA, QTY (B)(4) RECURRENT TUMOR, QTY (B)(4) ROD FRACTURE. ADVERSE EVENTS OF INTEREST AT 24 MONTHS POSTOPERATIVE: QTY (B)(4) BACK PAIN, QTY 1(B)(4) CSF (LED TO REOPERATION), QTY (B)(4) DURAL TEAR (LED TO REOPERATION), QTY (B)(4) FOOT DROP, QTY (B)(4) HEADACHE (FROM ADDITIONAL REOPERATION), QTY (B)(4) LOW BACK PAIN, QTY (B)(4) PLEURAL EFFUSION, QTY (B)(4) RECURRENCE TUMOR, QTY (B)(4) RECURRENT TUMOR, QTY (B)(4) SENSORY AND MOTOR ABNORMALITIES, QTY (B)(4) WOUND COMPLICATION (FROM ADDITIONAL REOPERATION). SERIOUS ADVERSE EVENTS OF INTEREST AT INTRA-OPERATIVE: QTY (B)(4) ACUTE BLOOD LOSS ANEMIA, QTY (B)(4) DURAL TEAR, QTY (B)(4) PLEURAL TEAR, QTY (B)(4) SPINAL CORD SIGNAL CHANGE (LED TO REOPERATION). SERIOUS ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY (B)(4) NEUROGENIC BLADDER, QTY (B)(4) PNEUMOTHORAX. SERIOUS ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY (B)(4) CSF LEAK, QTY (B)(4) HEADACHE, QTY (B)(4) INFECTION, QTY (B)(4) WOUND INFECTION. SERIOUS ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY (B)(4) ROD FRACTURE (TREATED WITH REVISION). SERIOUS ADVERSE EVENTS OF INTEREST AT 24 MONTHS POSTOPERATIVE: QTY (B)(4) CSF (LED TO REOPERATION), QTY (B)(4) DURAL TEAR (LED TO REOPERATION), QTY (B)(4) FOOT DROP, QTY (B)(4) HEADACHE (FROM ADDITIONAL REOPERATION), QTY (B)(4) LOW BACK PAIN, QTY (B)(4) PLEURAL EFFUSION, QTY (B)(4) RECURRENCE TUMOR (LED TO REOPERATION), QTY (B)(4) RECURRENT TUMOR (TREATED WITH REVISION), QTY (B)(4)WOUND COMPLICATION (FROM ADDITIONAL REOPERATION). AT COHORT IMPLANTED WITH THE EXPEDIUM POSTERIOR SPINE SYSTEM: ADVERSE EVENTS OF INTEREST AT INTRA-OPERATIVE: QTY (B)(4) CSF LEAK. ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY (B)(4) ACUTE BLOOD LOSS ANEMIA, QTY (B)(4) ANEMIA, QTY (B)(4) CONTINUED PARALYSIS, QTY (B)(4) LE SENSORY AND MOTOR ABNORMALITIES. ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY (B)(4) BACK PAIN, QTY (B)(4) LEG PAIN, QTY (B)(4) PLEURAL EFFUSION, QTY (B)(4) WOUND COMPLICATION. ADVERSE EVENTS OF INTEREST AT 3 MONTHS POSTOPERATIVE: QTY (B)(4) BACK PAIN, QTY (B)(4) FOOT DROP, QTY (B)(4) LOWER EXTREMITY PARESTHESIA. ADVERSE EVENTS OF INTEREST AT 6 MONTHS POSTOPERATIVE: QTY (B)(4) LOWER EXTREMITY MOTOR AND SENSOR ABNORMALITIES. ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY (B)(4) ACUTE BLOOD LOSS ANEMIA (ADDITIONAL REOPERATION), QTY (B)(4) BACK PAIN, QTY (B)(4) HARDWARE FAILURE (TREATED WITH REVISION), QTY (B)(4) LEG PAIN, QTY (B)(4) SI JOINT EDEMA. ADVERSE EVENTS OF INTEREST AT 24 MONTHS POSTOPERATIVE: QTY (B)(4) FALL, QTY (B)(4) LOWER EXTREMITY PARESTHESIA. SERIOUS ADVERSE EVENTS OF INTEREST AT INTRA-OPERATIVE: QTY (B)(4) ACUTE BLOOD LOSS ANEMIA. SERIOUS ADVERSE EVENTS OF INTEREST AT PRIOR TO DISCHARGE: QTY (B)(4) LE SENSORY AND MOTOR ABNORMALITIES. SERIOUS ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY (B)(4) PLEURAL EFFUSION. SERIOUS ADVERSE EVENTS OF INTEREST AT 12 MONTHS POSTOPERATIVE: QTY (B)(4) ACUTE BLOOD LOSS ANEMIA (ADDITIONAL REOPERATION), QTY (B)(4) HARDWARE FAILURE (TREATED WITH REVISION). IP-02097441: UNK - CONSTRUCTS: EXPEDIUM: ANTERIOR THIS IP CAPTURES SERIOUS ADVERSE EVENTS OF INTEREST AT 6 WEEKS POSTOPERATIVE: QTY (B)(4) CSF LEAK, QTY (B)(4) HEADACHE, QTY (B)(4) INFECTION, QTY (B)(4) WOUND INFECTION.

    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 (DDRA) FOR PATIENTS UNDERGOING: EXPEDIUM ANTERIOR STUDY ¿ UNY AT COHORT IMPLANTED WITH THE EXPEDIUM ANTERIOR SPINE SYSTEM. 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. ADVERSE EVENTS OF INTEREST (NOT NOTED AS SERIOUS) AT 6 WEEKS POSTOPERATIVE: QTY 1 ABDOMINAL BLOATING, QTY 1 ALTERED MENTATION, QTY 3 BACK PAIN, QTY 2 CSF LEAK, QTY 1 DURAL TEAR, QTY 1 HEADACHE, QTY 4 INFECTION, QTY 1 LEG PAIN, QTY 1 PLEURAL EFFUSION, QTY 1 VERTEBRAL BODY FRACTURE, QTY 2 WOUND COMPLICATION. ADVERSE EVENTS OF INTEREST (NOT NOTED AS SERIOUS) 3 MONTHS POSTOPERATIVE: QTY 1 BACK PAIN, QTY 1 FOOT DROP, QTY 1 LEG PAIN, QTY 1 LOWER EXTREMITY PARESTHESIA, QTY 1 WOUND COMPLICATION. ADVERSE EVENTS OF INTEREST (NOT NOTED AS SERIOUS) 6 MONTHS POSTOPERATIVE: QTY 1 BACK PAIN, QTY 1 LOWER EXTREMITY MOTOR AND SENSOR ABNORMALITIES. ADVERSE EVENTS OF INTEREST (NOT NOTED AS SERIOUS) 12 MONTHS POSTOPERATIVE: QTY 1 ACUTE BLOOD LOSS ANEMIA (ADDITIONAL REOPERATION), QTY 1 BACK PAIN, QTY 1 HARDWARE FAILURE (NO DETAILS PROVIDED ON SPECIFIC HARDWARE TREATED WITH REVISION), QTY 1 INFECTION, QTY 2 LEG PAIN, QTY 1 LOWER EXTREMITY PARESTHESIA, QTY 1 ROD FRACTURE, QTY 1 SI JOINT EDEMA. ADVERSE EVENTS OF INTEREST (NOT NOTED AS SERIOUS) 24 MONTHS POSTOPERATIVE: QTY 1 BACK PAIN, QTY 1 CSF (FROM ADDITIONAL REOPERATION), QTY 2 DURAL TEAR, QTY 1 FALL, QTY 1 FOOT DROP, QTY 2 HEADACHE (FROM ADDITIONAL REOPERATION), QTY 1 LOWER EXTREMITY PARESTHESIA, QTY 1 LOW BACK PAIN, QTY 1 PLEURAL EFFUSION, QTY 1 SENSORY AND MOTOR ABNORMALITIES. SERIOUS ADVERSE EVENTS OF INTEREST INTRA-OPERATIVE AND PRIOR TO DISCHARGE: QTY 1 ACUTE BLOOD LOSS ANEMIA, QTY 1 CSF LEAK (TREATED WITH REVISION), QTY 3 DURAL TEAR (QTY 2 WERE TREATED WITH REVISION), QTY 1 PLEURAL TEAR, QTY 1 SPINAL CORD SIGNAL CHANGE (TREATED WITH REVISION), QTY 1 LE SENSORY AND MOTOR ABNORMALITIES, QTY 1 NEUROGENIC BLADDER, QTY 1 PNEUMOTHORAX. SERIOUS ADVERSE EVENTS OF INTEREST 6 WEEKS POST OPERATIVE: QTY 1 CSF LEAK, QTY 1 HEADACHE, QTY 1 INFECTION, QTY 1 PLEURAL EFFUSION, QTY 1 WOUND INFECTION. SERIOUS ADVERSE EVENTS OF INTEREST 6 MONTHS POST OPERATIVE: QTY 1 LOWER EXTREMITY MOTOR AND SENSOR ABNORMALITIES. SERIOUS ADVERSE EVENTS OF INTEREST 12 MONTHS POST OPERATIVE: QTY 1 ACUTE BLOOD LOSS ANEMIA (ADDITIONAL REOPERATION), QTY 1 HARDWARE FAILURE, QTY 1 ROD FRACTURE (TREATED WITH REVISION). SERIOUS ADVERSE EVENTS OF INTEREST 12 MONTHS POST OPERATIVE: QTY 1 CSF LEAK, QTY 2 DURAL TEAR , QTY 1 FOOT DROP, QTY 2 HEADACHE, QTY 1 LOW BACK PAIN, QTY 1 PLEURAL EFFUSION, QTY 1 WOUND COMPLICATION. THIS REPORT INVOLVES AN UNKNOWN CONSTRUCTS: EXPEDIUM: ANTERIOR. THIS IS REPORT 3 OF 5 FOR (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479564 UNK - CONSTRUCTS: EXPEDIUM: ANTERIOR APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention