BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5

    MDR report key: 11740457 · Received April 28, 2021

    Report

    Report Number
    1526439-2021-00817
    Event Type
    Injury
    Date Received
    April 28, 2021
    Report Date
    April 2, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NBK
    UDI-DI
    10705034444291
    PMA / PMN Number
    K173095
    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. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT 5.5 EXP VERSE UNITIZED SET SCR COMPONENT THREADS WERE SLIGHTLY DEFORMED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE COMPLETE FUNCTIONAL TEST CANNOT BE PERFORMED AS ALL MATING DEVICES WERE NOT RETURNED AND COMPONENTS IN THE RECEIVED DEVICE WERE DAMAGED. THE OBSERVED CONDITION 5.5 EXP VERSE UNITIZED SET SCR COMPONENT IN THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING-RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE, NO MANUFACTURING RECORD EVALUATION IS REQUIRED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED DEFORM CONDITION OF 5.5 EXP VERSE UNITIZED SET SCR COMPONENT WOULD CONTRIBUTE TO THE COMPLAINED LOOSE ISSUE. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS PROBABLE THAT THE 5.5 EXP VERSE UNITIZED SET SCR IS DEFORMED DUE TO THE UNINTENDED FORCES. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED? THE FOLLOWING DRAWING REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED: EXPEDIUM VERSE SINGLE LOCK. 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

    PRODUCT COMPLAINT#: (B)(4). 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. H10 ADDITIONAL NARRATIVE: H11: D1: BRAND NAME. D2: ADDITIONAL PRODUCT CODE : OSH, MNI, MNH. D4: PART NUMBER, LOT# & UDI UPDATED. G1: MANUFACTURE SITE. 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. D1: BRAND NAME. D2: ADDITIONAL PRODUCT CODE: OSH, MNI, MNH. D4: PART NUMBER, LOT# & UDI UPDATED. G1: MANUFACTURE SITE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE : KWP, KWQ. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON AN UNKNOWN DATE THAT THE PATIENT WAS FOUND THAT THE SCREWS WHICH WERE DEPLOYED IN THE RIGHT ILIUM HAD COME OFF THE ROD. HE UNDERWENT FOR A REVISION SURGERY FOR ROD FUSION, AND IT WAS CONFIRMED THAT REMAINING SCREWS HAD NOT BEEN LOOSE. THE PLF REVISION PROCEDURE WAS PERFORMED TO EXTEND THE FUSION RANGE UP THE ILIUM ON (B)(6) 2021. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN ROD HOLDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001S, LOT# XP1233, QUANTITY 1). SINGLE-INNER SETSCREW (PART# 179702000, LOT# 286895, QUANTITY 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 8.0X60. THIS REPORT IS 2 OF 3 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636664 EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NBK MEDOS INTERNATIONAL SàRL CH 199723860S XP1233 10705034444291

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 5.5 EXP VERSE FEN SCR 8.0X60| SINGLE-INNER SETSCREW| UNKNOWN LOCKING/SET SCREWS| UNKNOWN ROD HOLDER| UNKNOWN RODS| UNKNOWN TIGHTENER