BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XRL LARGE IMPLANT-INTEGRATED 29MM-37MM HEIGHT/0 DEG-STERILE

    MDR report key: 6768360 · Received August 4, 2017

    Report

    Report Number
    1719045-2017-10739
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    May 30, 2017
    Report Date
    May 30, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQP
    PMA / PMN Number
    K103320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED. ONE (1) XRL LARGE IMPLANT, INTEGRATED 0 DEGREE, 29-37MM, STERILE (08.807.303S, ETCHED LOT 6924439/LEGAL LOT 6982807, MFG 16-JULY-2012) WAS RETURNED WITH A COMPLAINT STATING THAT THE IMPLANT BROKE INTRAOPERATIVELY. THE FRAGMENT PIECE WAS RETRIEVED. UPON FURTHER OBSERVATION, IT WAS NOTED THAT THE INCORRECT SPREADER [TOP] WAS ATTACHED TO THE IMPLANT WHICH MAY HAVE CAUSED IT TO NOT ENGAGE WITH THE IMPLANT INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT IMPLANT SIZE. THE DEVICE WAS EVALUATED AT CUSTOMER QUALITY AND THE COMPLAINT CONDITION OF BROKEN WAS ABLE TO BE CONFIRMED. THE SUPERIOR SECTION OF THE INNER BODY HAS CHIPPED OFF IN TWO LOCATIONS. A LARGE FRAGMENT WAS RETURNED BUT TWO SMALL FRAGMENTS WERE NOT RETURNED. A VISUAL INSPECTION, DEVICE HISTORY RECORD REVIEW, RISK ASSESSMENT REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. NO NEW MALFUNCTIONS WERE IDENTIFIED DURING THE INVESTIGATION. THE XRL VERTEBRAL BODY REPLACEMENT DEVICE IS A MODULAR EXPANDABLE RADIOLUCENT VERTEBRAL BODY REPLACEMENT SYSTEM INDICATED FOR THE THORACOLUMBAR SPINE. THE SPREADER IS USED IN CONJUNCTION WITH A XRL SHAFT AND XRL RELEASE TOOL TO INSERT THE XRL IMPLANT. RELEVANT PRODUCT DRAWINGS WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITIONS MENTIONED ABOVE. BASED ON THE COMPLAINT DESCRIPTION, THE ROOT CAUSE OF THE BREAKAGE IS DETERMINED TO BE SURGICAL TECHNIQUE RELATED. THE XRL TECHNIQUE GUIDE STATES ¿TO ASSEMBLE THE APPROPRIATE SIZE SPREADER TOP TO THE XRL SPREADER ACCORDING TO THE IMPLANT CENTRAL BODY SIZE SELECTED.¿ DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). DHR REVIEW COMPLETED. PART #: 08.807.303S, LOT#: 6982807 (STERILE) ¿ XRL LARGE IMPLANT-INTEGRATED 29MM-37MM HEIGHT/0 DEG - STERILE. QUANTITY 10. COMPONENT PART: 08.807.303Y, LARGE INTEGRATED ASMB 28-36 0. LOT-6924439. (B)(4) RELEASED PRODUCT 03-JUL-2012. PRODUCT DRAWING, PLASMA TREATMENT, INTEGRATED ASSEMBLY, LARGE, MEETS ACCEPTANCE CRITERIA OF INSPECTION SHEET. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 16-JUL-2012. EXPIRATION DATE: 30-JUN-2022. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORPECTOMY AT L1 ON (B)(6) 2017. INTRAOPERATIVELY, THE OPERATING ROOM TECHNICIAN COULD NOT ENGAGE THE IMPLANT WITH THE IMPLANT INSERTER AT THE BACK TABLE. THE SURGEON TRIED TO ENGAGE THE DEVICES AND THE IMPLANT BROKE INTO SEPARATE TWO PIECES. THE FRAGMENT PIECE WAS RETRIEVED. UPON FURTHER OBSERVATION, IT WAS NOTED THAT THE INCORRECT SPREADER TIP WAS ATTACHED TO THE IMPLANT WHICH MAY HAVE CAUSED IT TO NOT ENGAGE WITH THE IMPLANT INSERTER. A NEW IMPLANT WAS BUILT (IT WAS DIFFERENT SIZE FROM FIRST IMPLANT) AND USING A DIFFERENT SPREADER TIP, IT WAS ATTACHED TO THE IMPLANT THAT DID ENGAGE WITH THE IMPLANT INSERTER. THERE WAS A PROBLEM GETTING THE SECOND DEVICE IMPLANTED DUE TO THE PATIENT¿S ANATOMY. THE SC REPORTED THE DIFFICULTY HAD NOTHING TO DO WITH THE IMPLANT OR THE IMPLANT INSERTER. THE SECOND DEVICE WAS NOT IMPLANTED; THE SURGEON INSTEAD COMPLETED THE PROCEDURE BY IMPLANTING MESH IN THE PATIENT WITHOUT UNTOWARD EFFECT. THESE EVENTS DID RESULT IN A 5 MINUTE SURGICAL DELAY. NO HARM REPORTED TO PATIENT. THE PATIENT OUTCOME WAS REPORTED STABLE. CONCOMITANT DEVICES REPORTED: IMPLANT INSERTER(PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), SPREADER TIP (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) XRL LARGE IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548285 XRL LARGE IMPLANT-INTEGRATED 29MM-37MM HEIGHT/0 DEG-STERILE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES MONUMENT 6982807

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention