BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CANCELLOUS POLYAXIAL SCREW 20MM FOR 4.0MM RODS

    MDR report key: 7769626 · Received August 9, 2018

    Report

    Report Number
    8030965-2018-55599
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    July 24, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKG
    UDI-DI
    07611819477261
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE PROVIDED X-RAYS WAS COMPLETED: THE COMPLAINT IS CONFIRMED AS ON THE RECEIVED PICTURES BOTH HEADS WERE SEPARATED FROM THE ROD, ONE HEAD IS ALSO SEPARATED FROM THE SCREW HEAD. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    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. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.615.120, LOT# 7360270 . MANUFACTURING LOCATION: BRANDYWINE, MANUFACTURING DATE: APR 17, 2013. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON CONFORMANCE REPORTS WERE GENERATED FOR THE DEVICE'S RAW MATERIALS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE DEVICES' RAW MATERIALS SHOWED THAT THERE WERE NO ISSUES WITH THE PRODUCT'S RAW MATERIALS THAT WOULD CONTRIBUTE TO THIS COMPLAINT ACTION. PRODUCT INVESTIGATION WAS COMPLETED. THE RECEIVED IMAGES OF THE COMPLAINANT DEVICES WERE REVIEWED, SHOWING THAT ONE POLYAXIAL NEUTRAL BODY SEPARATED FROM ITS SCREW; IT COULD NOT BE CONFIRMED FROM THE IMAGES WHETHER A SECOND NEUTRAL BODY HAD SEPARATED FROM ITS SCREW. AS BOTH RETURNED SCREW ASSEMBLIES WERE FROM THE SAME LOT AND COULD NOT BE DISTINGUISHED FURTHER, THIS INVESTIGATION IS FOR THE FIRST SCREW ASSEMBLY THAT COULD BE CONFIRMED AS SEPARATING/FALLING APART. IT WAS NOTED DURING REVIEW OF THE RECEIVED IMAGES THAT THE HEAD OF THE SCREW ASSEMBLY WAS SEPARATED FROM THE SCREW. THE SCREW ASSEMBLY WAS RETURNED WITH THE CANCELLOUS SCREW COMPONENT (04.615.120) SEPARATED FROM THE REMAINING COMPONENTS: THE BUSHING (04.614.008.32) AND SLEEVE (04.614.008.42) WERE APPROPRIATELY ATTACHED/ASSEMBLED TO THE NEUTRAL BODY (04.615.008.2). NO MAJOR DAMAGE WAS NOTED TO THE SCREW, BUSHING, OR SLEEVE COMPONENTS. WEAR ON THE EXTERIOR OF THE BODY COMPONENT WAS NOTED, WHICH WAS CONSISTENT WITH IMPLANTATION AND EXPLANTATION. A BROKEN CONDITION OF ANY COMPONENTS WAS NOT OBSERVED; THE RECEIVED CONDITION DID NOT AGREE WITH THIS COMPLAINT CONDITION, AND THE BROKEN CONDITION IS NOT CONSIDERED CONFIRMED. PER THE IMAGES, THE SCREW WAS CONFIRMED TO HAVE SEPARATED/FELL APART FROM THE HEAD WHILE IMPLANTED. ADDITIONALLY, AS THE SCREW WAS RECEIVED APART FROM THE HEAD, THE RECEIVED CONDITION AGREED WITH THE COMPLAINT DESCRIPTION. INSERTION OF THE SCREW INTO THE BUSHING BY HAND THROUGH THE BOTTOM/VENTRAL OPENING WAS POSSIBLE DURING INVESTIGATION; THE SCREW THEREFORE WAS EASILY SEPARATED FROM THE BUSHING. THE RECEIVED CONDITION OF THE SCREW ASSEMBLY AGREED WITH THE COMPLAINT CONDITION - THE FUNCTIONAL COMPLAINT OF THE SCREW SEPARATING FROM THE HEAD WAS REPLICATED. THE DIAMETER ACROSS THE SPHERICAL HEAD OF THE CANCELLOUS SCREW COMPONENT (04.615.120) MEASURED 4.673MM, WHICH WAS WITHIN SPECIFICATION OF 4.69MM +/-0.02 PER DRAWING . MEASURED WITH OM800. THE DIAMETER ACROSS THE BOTTOM/VENTRAL OPENING OF THE BUSHING MEASURED 4.68MM, WHICH WAS ABOVE THE REFERENCE DIMENSION OF 4.39MM PER DRAWING. THE REFERENCE DIMENSION DOES NOT DEFINE THE FEATURE'S GEOMETRY AND WAS NOT USED BY MANUFACTURING. HOWEVER, IT IS BEING CONSIDERED IN THIS INVESTIGATION BECAUSE OF THE APPARENT DISCREPANCY BETWEEN THE ACTUAL DIMENSION AND EXPECTED REFERENCE DIMENSION. THE BUSHING IS THEREFORE CONSIDERED DEFORMED. RELEVANT DRAWINGS WERE REVIEWED DURING INVESTIGATION. DURING THE INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION WAS CONFIRMED DURING INVESTIGATION. THE SCREW COMPONENT WAS RECEIVED SEPARATED FROM THE REMAINING COMPONENTS OF THE SCREW ASSEMBLY. DIMENSIONAL INSPECTION NOTED THE BOTTOM/VENTRAL OPENING OF THE BUSHING WAS ABOVE THE REFERENCE DIMENSION INDICATING DEFORMATION OF THE BUSHING, WHICH ALLOWED THE SCREW COMPONENT TO PASS THROUGH THIS FEATURE. IT IS LIKELY THAT THIS DEFORMATION OCCURRED WHEN THE DEVICE WAS EXPOSED TO EXCESSIVE FORCES WHILE IMPLANTED. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. 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

    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. ADDITIONAL NARRATIVE: CODE 3191 USED TO CAPTURE REQUIRED SURGICAL INTERVENTION AND DEVICE REMOVAL. CORRECTED DATA: PATIENT CODES. 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 · 0

    ADDITIONAL CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART 04.614.508, LOT 9810858, QUANTITY 1); LOCKING SCREW (PART 04.614.508, LOT 7921262, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES: KWP, MNH, MNI. DATE OF IMPLANT REPORTED AS (B)(6) 2015, EXACT DATE IS NOT KNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS SYNTHES SALES CONSULTANT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A POSTERIOR CERVICAL FIXATION PROCEDURE WITH THE SYNAPSE SYSTEM ON UNKNOWN DATE IN (B)(6) 2015. ON UNKNOWN DATE PATIENT REPORTED PAIN. X-RAY AND MAGNETIC RESONANCE IMAGING (MRI) ON UNKNOWN DATE REVEALED THAT THE TULIP HEAD OF TWO (2) OF THE 4.0MM CANCELLOUS POLYAXIAL SCREWS HAD SEPARATED FROM THE SCREW SHAFT. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE BROKEN SCREWS WERE REMOVED AND REPLACED WITH NEW SCREWS. CONCOMITANT DEVICES REPORTED: SYNAPSE ROD (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.0MM CANCELLOUS POLYAXIAL SCREW 30MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609371 4.0MM TI CANCELLOUS POLYAXIAL SCREW 20MM FOR 4.0MM RODS ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG OBERDORF SYNTHES PRODUKTIONS GMBH 7360270 07611819477261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention