BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKY VARIABLE S-D SCW 16MM TI

    MDR report key: 11486085 · Received March 15, 2021

    Report

    Report Number
    1526439-2021-00442
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    February 15, 2021
    Report Date
    February 16, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    UDI-DI
    10705034134109
    PMA / PMN Number
    K052552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PPRODUCT 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. H3, H6: INVESTIGATION SUMMARY. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE SKY VARIABLE S-D SCW 16MM TI (P/N: 186850016, LOT #235497) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE SCREW IS BROKEN AT THE DISTAL END WHICH IS CONSISTENT WITH THE COMPLAINT CONDITION. THE BROKEN PIECES WERE NOT RETURNED. THE DEVICE FAILURE / DEFECT WAS IDENTIFIED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. THE COMPLAINT WAS CONFIRMED. THE DEVICE RECEIVED IS BROKEN. HENCE THE ALLEGATION CAN BE CONFIRMED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE THE SKY VARIABLE S-D SCW 16MM TI (P/N: 186850016, LOT # 235497). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. DEVICE HISTORY LOT: THE DHR OF PRODUCT CODE: 186850016, LOT : 235497, WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 19.03.2019, QTY: (B)(4). DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE. 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 · 1

    PRODUCT COMPLAINT #: (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. CUSTOMER QUALITY INVESTIGATION: THE IMPLANT(S) WAS NOT RETURNED, AND THE INVESTIGATION WILL BE COMPLETED BASED ON THE SUPPLIED IMAGE(S). THE IMAGE(S) WAS REVIEWED, AND THE COMPLAINT CONDITION OF BROKEN WAS CONFIRMED AS THE IMAGE(S) SHOWED SEVERAL BROKEN SCREWS ALONG THE SPINE. AS THE IMPLANT(S) WAS NOT RETURNED AND AS RECEIVED, DIMENSIONAL, MATERIAL OR DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT AS THE CIRCUMSTANCES DURING THE TIME OF THE EVENT ARE UNKNOWN. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION (BASED ON THE IMAGES) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE. 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 ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY FOR A SKYLINE PLATE/SCREWS AS THE SCREWS HAD FRACTURED. THE SCREWS HAD FRACTURED IN THE VERTEBRAL BODY AND METALS WAS SUBSEQUENTLY LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S18155241049, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM (PART# S17197051079, LOT# UNKNOWN, QUANTITY 1); BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM (PART# S1816613-1034, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) SKY VARIABLE S-D SCW 16MM TI. THIS REPORT IS 5 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386100 SKY VARIABLE S-D SCW 16MM TI APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH 186850016 235497 10705034134109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM| BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM| BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM| SKY 3 LEVEL PLTE 54MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM| BONE VERTIGRAFT CERVICAL TRAPEZOID 5*7MM| BONE VERTIGRAFT CERVICAL/TRAP FD 6*8MM| SKY 3 LEVEL PLTE 54MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI| SKY VARIABLE S-D SCW 16MM TI