BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RODS

    MDR report key: 10445999 · Received August 24, 2020

    Report

    Report Number
    1526439-2020-01512
    Event Type
    Injury
    Date Received
    August 24, 2020
    Report Date
    July 25, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 CORRECTED DATA. B5. D11. 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.

    Description of Event or Problem · 0

    UPDATED: CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE UNITIZED SET SCR(PART# 199721001S, LOT# WE1112, QUANTITY 1). 5.5 EXP VERSE CAN SCR 6.0X45 (PART# 199725645, LOT# 221038, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN ROD/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SECOND REVISION SURGERY ON (B)(6) 2020 DUE TO SETSCREW LOOSENING AND THE ROD WAS ABOUT TO COME OFF THE SCREWHEAD. ALL THE SETSCREWS WERE REMOVED AND ANOTHER MANUFACTURER¿S SETSCREWS WERE USED AS REPLACEMENTS, AND RE-FUSION WAS PERFORMED TO TREAT ADJACENT DISEASE. THE SURGEON COMMENTED THAT THERE MIGHT HAVE BEEN CROSS-THREADING ON THE SETSCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT (B)(4) IS RELATED TO COMPLAINT (B)(4), WHICH REPORTS THE FIRST REVISION PROCEDURE WHICH WAS PERFORMED FOR REMOVING THE BLOOD TUMOR BY DETACHING A CROSS-LINK DEVICE AND REPLACING WITH A NEW ONE. CONCOMITANT DEVICE REPORTED: 5.5 EXP VERSE UNITIZED SET SCR(PART# 199721001S, LOT# WE1112, QUANTITY 1); 5.5 EXP VERSE CAN SCR 6.0X45 (PART# 199725645S, LOT# 221038, QUANTITY 1). THIS REPORT IS FOR UNKNOWN ROD. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907285 UNKNOWN RODS APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5.5 EXP VERSE CAN SCR 6.0X45.| 5.5 EXP VERSE UNITIZED SET SCR.| 5.5 EXP VERSE UNITIZED SET SCR.