BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS CORD

    MDR report key: 7103618 · Received December 11, 2017

    Report

    Report Number
    0009613350-2017-01720
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    November 10, 2017
    Report Date
    March 7, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: ITEM: DYNESYS, UNIVERSAL SPACER, 6-45 CATALOG #: 01.03706.045 LOT #: 2812117. ITEM: ZIMMER DTO 5.5 IMPLANT OUS 50MM 2PCS CATALOG #: 01.04001.050 LOT #: 2790244. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. CURRENTLY, ADDITIONAL INFORMATION IS NOT AVAILABLE. DHR-REVIEW: AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: RUPTURE OF THE DYNESYS CORD. EVENT DESCRIPTION: THE PATIENT RETURNED TO THE SURGEON WITH RECURRENT PAIN ON THE LEFT SIDE OF THE LUMBAR REGION. A SCAN SHOWED THAT THE SPACER WAS NOT ALIGNING PROPERLY WITH THE DTO IMPLANT. THE SURGEON DECIDED TO REMOVE THE SCREWS AND CONNECTIONS. DURING EXPLANTATION, IT WAS FOUND THAT THE CORD WAS RUPTURED AT THE CORD-ROD INTERFACE. REVIEW OF AVAILABLE INFORMATION: THE CONTAINER IN WHICH THE EXPLANTS WERE RECEIVED WAS LABELED WITH A PATIENT STICKER. THE REPORTED EVENT WAS DESCRIBED AS FOLLOWS: ¿PATIENT RETURNED TO SURGEON WITH RECURRENT PAIN ON LEFT SIDE OF THE LUMBAR REGION. A SCAN SHOWED THAT THE SPACER WAS NOT ALIGNING PROPERLY WITH THE DTO IMPLANT AND A FRACTURE OF THE CORD WAS ASSUMED. AS THE DISC OF THE TREATED LEVEL WAS REGENERATED AND THE LOWER LEVEL WAS FUSED THE SURGEON DECIDED TO REMOVE THE SCREWS AND CONNECTIONS. DURING EXPLANTATION, WE COULD CLEARLY SEE THAT THE CORD INDEED WAS BROKEN AT THE CORD-ROD INTERFACE. DEVICES ANALYSIS: - VISUAL EXAMINATION IN THE AS-RECEIVED CONDITION THE CORD OF THE DTO IMPLANT WAS SEPARATED FROM ITS ROD AND WAS STILL LOCATED IN THE SPACER¿S CHANNEL FOR PROPER CLEANING THE CORD WAS REMOVED FROM THE SPACER. THE ROD OF THE DTO IMPLANT SHOWS SEVERAL DIFFUSE SCRATCHES. ON THE BLASTED AREA THREE DIFFERENT DISTINCT MARKS ARE OBSERVABLE. ONE MARK WHICH CONSISTS OF THREE SINGLE SMALL POLISHED ZONES IN A LINE CAN BE SEEN ON THE POSTERIOR SIDE. WHEREAS THE MIDDLE ZONE IS AN INDENTATION AND HAS AN OVAL SHAPE THE OTHER TWO SEEM TO BE ONLY A POLISHING OF THE SURFACE. THE LATTER TWO PROBABLY DERIVED FROM CONTACT WITH THE SET SCREW BUT THE ORIGIN OF THE INDENTATION IS UNKNOWN. ON THE ANTERIOR SIDE AND ON ONE OF THE SIDE SURFACES A PERFECT OVAL MARK AND A PERFECT RECTANGULAR MARK CAN BE DETECTED HAVING A SIMILAR MACROSCOPIC APPEARANCE WHICH IS DIFFERENT FROM THAT OF THE OTHER ABOVE MENTIONED MARK. CLOSER INSPECTION WITH A MICROSCOPE TYPE LEICA MZ16 A SHOWED THAT THE OVAL MARK IS BORDERED BY A BLUEISH LINE AND IS PARTIALLY SLIGHTLY POLISHED INSIDE. THE RECTANGULAR MARK HAS A POLISHED APPEARANCE WITH DIAGONAL TRACES. IT IS UNKNOWN WHERE THESE TWO MARKS RESULTED FROM. THE POLISHED HEAD OF THE ROD EXHIBITS SOME SMALL MARKS WHICH MOST PROBABLY DERIVED FROM CONTACT WITH THE OPTIMA ZS TRANSITION SCREW AND SET SCREW RESPECTIVELY. THE CORD RUPTURE OCCURRED DIRECTLY ON THE LEVEL OF THE ROD¿S END SO THAT THE REMAINING CORD PIECE IS FLUSH WITH THE ROD¿S END AND DOES ALMOST NOT STICK OUT OF THE ROD. THE REMAINING CORD PIECE IS PARTIALLY INFILTRATED BY ORGANIC DEPOSITS, APPROXIMATELY THREE QUARTERS OF THE FIBER BUNDLES ARE "FEAZED" AND THE SINGLE FIBERS FORM A LOOSE FELT-LIKE STRUCTURE. THE RUPTURED CORD PIECE HAS A THICKENED APPEARANCE ON THE RUPTURED SIDE. THE OUTER CORD LAYER PROTRUDES IMPERCEPTIBLY FROM THE INNER CORD LAYERS. THERE ARE ORGANIC DEPOSITS INSIDE THE CORD AS WELL. THE FIBER BUNDLES OF THE OUTER CORD LAYER SEEM TO BE FRAYED BUT STILL COMPACTED TO A FELT-LIKE STRUCTURE. THE OTHER CORD END IS SMALLER IN DIAMETER AND THE FIBER BUNDLES ARE FEAZED SO THAT THE SINGLE FIBERS ARE RECOGNIZABLE. HOWEVER, THE LATTER ARE NOT FELTED WITH EACH OTHER. ON THE RUPTURED CORD PIECE THE FIXATION AREA WHERE THE DYNESYS PEDICLE SCREW WAS LOCATED IS CLEARLY RECOGNIZABLE. IN THIS AREA THE CORD IS FLATTENED AND THE FIBER BUNDLES ARE DAMAGED AT THE POINT WHICH WAS IN CONTACT WITH THE TIP OF THE SET SCREW. THE DYNESYS SPACER HAS A SLIGHT CURVATURE IN LONGITUDINAL DIRECTION AND SOME SCRATCHES. THE LATTER MOST LIKELY DERIVED FROM REVISION SURGERY. INDENTATIONS FROM THE ROD¿S END AND THE DYNESYS SCREW HEAD RESPECTIVELY COULD BE FOUND ON THE FRONT SURFACES. ON THE SPACER¿S FRONT SURFACE FACING THE ROD THERE ARE SMALL DULL ZONES. THE APPEARANCE OF THE LATTER COULD POSSIBLY POINT TO DEPOSITS. ON THE SPACER¿S FRONT SURFACE FACING THE SCREW SMALL DULL ZONES ARE VISIBLE WHICH CAN BE ATTRIBUTED TO ABRASION. ADDITIONALLY, THERE IS A GREATER DULL ZONE OF DEPOSITS. INDENTATIONS OF THE CORD¿S STRUCTURE ARE PRESENT IN THE ENCLOSED CHANNEL OF THE SPACER. FURTHERMORE, IN THE CHANNEL A SMALL DULL AREA CAN BE SEEN LOCATED ON THE END OF THE SPACER FACING THE ROD. DETAILED INSPECTION WITH A MICROSCOPE TYPE LEICA MZ16 A REVEALED PROBABLY A MIXTURE OF ORGANIC DEPOSITS AND ABRASION AS IT SEEMS THAT THE SURFACE SHOWS SIGNS OF A FINE WAVELIKE RIBBED STRUCTURE. CONCLUSION: THE PATIENT RETURNED TO THE SURGEON WITH RECURRENT PAIN ON THE LEFT SIDE OF THE LUMBAR REGION. A SCAN SHOWED THAT THE SPACER WAS NOT ALIGNING PROPERLY WITH THE DTO IMPLANT. THE SURGEON DECIDED TO REMOVE THE SCREWS AND CONNECTIONS. DURING EXPLANTATION, IT WAS FOUND THAT THE CORD WAS RUPTURED AT THE CORD-ROD INTERFACE. THE EXPLANTS SHOW THAT THE CORD RUPTURE OCCURRED DIRECTLY ON THE LEVEL OF THE ROD¿S END SO THAT THE REMAINING CORD PIECE IS FLUSH WITH THE ROD¿S END AND DOES ALMOST NOT STICK OUT OF THE ROD. THE RUPTURED CORD ENDS HAVE A FELT-LIKE STRUCTURE THAT IS LOOSE ON THE ROD¿S SIDE AND COMPACT STRUCTURE ON THE CORD¿S SIDE. DUE TO THE RUPTURE ORGANIC DEPOSITS COULD GET INSIDE THE CORD. IN THE CHANNEL OF THE SPACER CLOSE TO ITS END FACING THE ROD SIGNS OF ABRASION COULD BE FOUND. IT COULD PROBABLY BE ASSUMED THAT THE RUPTURED CORD END RUBBED VERY SLIGHTLY AGAINST THE SPACER¿S CHANNEL. ON THE SPACER¿S FRONT SURFACE FACING THE SCREW SMALL DULL ZONES ARE VISIBLE WHICH CAN BE ATTRIBUTED TO ABRASION AND COULD INDICATE SOME MICROMOVEMENT. BASED ON THE RETRIEVAL ANALYSIS ONLY AND WITHOUT FURTHER INFORMATION, E.G. PATIENT AND CLINICAL INFORMATION, THE REASON FOR THE CORD RUPTURE CANNOT BE EXPLAINED. THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2017-01722. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS IMPLANTED WITH A DYNESYS CORD (CATALOG AND LOT NUMBER UNKNOWN) ON AN UNKNOWN DATE. PATIENT RETURNED TO SURGEON WITH RECURRENT PAIN ON LEFT SIDE OF THE LUMBAR REGION. A SCAN SHOWED THAT THE SPACER WAS NOT ALIGNING PROPERLY WITH THE DTO IMPLANT AND A FRACTURE OF THE CORD WAS ASSUMED. AS THE DISC OF THE TREATED LEVEL WAS REGENERATED AND THE LOWER LEVEL WAS FUSED THE SURGEON DECIDED TO REMOVE THE SCREWS AND CONNECTIONS. DURING THE EXPLANTATION (DATE U UNKNOWN), IT COULD BE CLEARLY SEE THAT THE CORD INDEED WAS BROKEN AT THE CORD-ROD INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886384 DYNESYS CORD NA NQP ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R