BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER-MEDIUM

    MDR report key: 5860650 · Received August 9, 2016

    Report

    Report Number
    9680938-2016-10122
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 21, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE HISTORY RECORD REVIEW OF THE PAST THREE YEARS FOR THE SUBJECT DEVICE HAS BEEN REVIEWED. IT WAS REVEALED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE RELEASE TO WAREHOUSE DATE (DATE OF MANUFACTURE) FOR THIS DEVICE WAS SEP 25, 2006. THE SERVICE HISTORY RECORD REVIEW IS UNCONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: (B)(4). THE REVIEW REVEALED THERE WERE SEVERAL DIFFERENT MANUFACTURING DATES FOR THIS LOT NUMBER: JUL 7, 2006. JUL 11, 2006. JUL 13, 2006, JUL 20, 2006, JUL 21, 2006, JUL 25, 2006, SEP 25, 2006 AND OCT 5, 2006. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS, ALL (B)(4) PARTS OF THE LOTS WERE CHECKED 100% FOR CTQ FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION. 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

    ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION WAS COMPLETED: A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, PARTIAL FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AND NO FUNCTIONAL OR DIMENSIONAL ISSUES WERE IDENTIFIED WITH THE RETURNED PARTS. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THUS, AS NO ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICES, FURTHER INVESTIGATION IS NOT WARRANTED. THE RETURNED MEDIUM INSERTER AND MEDIUM POLYETHYLENE INLAY IMPLANT ARE PART OF THE PRODISC-L TOTAL DISC REPLACEMENT SYSTEM. THE PRODISC-L SYSTEM IS ¿INTENDED TO REPLACE A DISEASED AND/OR DEGENERATED INTERVERTEBRAL DISC OF THE LUMBOSACRAL REGION¿ BETWEEN L3 AND S1. THE INSERTER IS USED TO INSERT THE ENDPLATES AND THEN USED WITH THE DISTRACTOR AND THE INLAY PUSHER TO INSERT THE POLYETHYLENE INLAY. THE INSERTERS AND IMPLANT WERE RECEIVED INTACT WITH SURFACE WEAR CONSISTENT WITH USE. THE MEASUREMENT ACROSS THE LEDGES OF THE INLAY WHICH ARE THE WIDEST PORTION OF THE IMPLANT AND RESPONSIBLE FOR MATING WITH THE INSERTER WERE CONFIRMED TO BE WITHIN THE SPECIFICATION OF 23MM +0/-0.1 AT 22.94MM AS MEASURED WITH MICROMETERS OM33. THE INNER EDGES OF THE LEDGES WERE ALSO CONFIRMED TO BE WITHIN THE SPECIFICATION OF 21MM +0/-0.1 AT 20.93MM AS MEASURED WITH MICROMETERS OM33. THE SLOTS ALONG THE ARM COMPONENT OF EACH INSERTER WERE INSPECTED AND NO DAMAGE WAS OBSERVED. THE SLOTS PROPERLY MATED WITH THE RETURNED IMPLANT WHEN HELD IN POSITION. HOWEVER, AS THE INFERIOR ARMS OF THE INSERTER ARE DESIGNED TO ROTATE AND LOCK INTO THE INFERIOR PLATE, ESTABLISHING A FIXED DISTANCE BETWEEN THE TWO ARMS THAT WOULD ALLOW THE POLYETHYLENE INLAY TO SLIDE WITHIN THE GROOVE, A FULL FUNCTIONAL TEST COULD NOT BE PERFORMED. THUS, REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE ADJOINING IMPLANTS AND INSTRUMENTS WERE NOT RECEIVED. IN CONCLUSION, THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AND NO FUNCTIONAL OR DIMENSIONAL ISSUES WERE IDENTIFIED WITH THE RETURNED PARTS. A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION FOR THE TOP LEVEL, THE INSERTER ARM COMPONENT WITH STOP, THE INSERTER ARM COMPONENT WITHOUT STOP, THE TOP LEVEL AND THE DETAILED INLAY WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. IN CONCLUSION, THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AND NO FUNCTIONAL OR DIMENSIONAL ISSUES WERE IDENTIFIED WITH THE RETURNED PARTS. THUS, AS NO ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICES, FURTHER INVESTIGATION IS NOT WARRANTED. NO FUNCTIONAL OR DIMENSIONAL ISSUES WERE IDENTIFIED WITH THE RETURNED PARTS. THUS, GIVEN THE UNCONFIRMED CONDITION AND THE UNKNOWN CIRCUMSTANCES AT THE TIME OF THE ISSUE A ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. DEVICE 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL LUMBAR DISC ARTHROPLASTY SURGERY ON THE L5, S1, THAT THE SUPERIOR AND INTERIOR PRO-DISC END PLATES WERE IMPLANTED IN THE PATIENT WITH A MEDIUM SIZED PRO-DISC HOLDER. THE SURGEON THEN SLIDE THE POLY-INLAY DOWN THE TRACKS OF THE HOLDER. THE INLAY KEPT POPPING OFF THE TRACKS OF THE HOLDER. THE SURGEON CHANGED THE ONE POLY-INLAY WITH ANOTHER POLY-INLAY. THE SURGEON THOUGHT THAT THE DEFECTIVE DEVICE WAS A POLY-INLAY. THE SURGEON THEN SWITCHED OUT THE OTHER IMPLANT HOLDER, AND THAT DID NOT HELP. THE SURGEON KEPT WORKING TO MAKE IT FUNCTION, AND THE INLAY WAS FINALLY IMPLANTED. THE SURGEON STATED THAT THERE MAY BE A DEFECT IN EITHER THE INLAY OR THE TWO HOLDERS. THE DISTANCE BETWEEN THE TRACKS MAY HAVE BEEN EITHER NARROWER THAN IT SHOULD HAVE BEEN, OR THAT THE SURGEON WAS NOT GETTING THE INLAY ON THE TRACK PROPERLY. THERE WAS ABOUT A 20 MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF MEDICAL INTERVENTION. THE PATIENT'S POST-OPERATIVE STATUS WAS NOTED TO BE STABLE. THIS COMPLAINT HAS 4 DEVICES. CONCOMITANT DEVICES REPORTED: PART #-PDL-M-SP11S, LOT #-7807317, QUANTITY-(1); PDL-M-IT00S, LOT #-9911798, QUANTITY-(1). THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511872 INSERTER-MEDIUM MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES TUTTLINGEN A7PA27

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR